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  <trial lastUpdated="2023-10-23T10:35:50.750029Z" version="44" isPublished="true" publicIdentifierType="isrctn" publicIdentifierCanonical="ISRCTN81104604" publicIdentifierDateAssigned="2023-01-03T11:12:00.317468Z">
    <isrctn dateAssigned="2023-01-03T11:12:00.317468Z">81104604</isrctn>
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      <title>Evaluating a training workshop for high-intensity therapists to improve how well depression and anxiety treatments in Improving Access to Psychological Therapies (IAPT) services are tailored for clients who also experience difficulties managing their emotions, relationships and sense of self</title>
      <scientificTitle>A multi-site mixed-methods evaluation of brief Improving Access to Psychological Therapies (IAPT) staff training to adapt practice for secondary personality difficulties</scientificTitle>
      <acronym/>
      <studyHypothesis>This is a pilot and feasibility study, so the main aim of the work is to preliminarily examine the feasibility and acceptability of the workshop and the evaluation process, and we have not laid out a priori hypotheses. However, we have laid out a set of continuation rules to aid decision-making as to whether to proceed to definitive evaluation without modification, this includes establishing proof-of-concept that the workshop leads to improvements in therapist attitudes (perceived knowledge skill and confidence) to work with this client group.</studyHypothesis>
      <plainEnglishSummary>Background and study aims
Some people have difficulties managing their relationships, emotions or sense of self, some of whom have lived through adverse early life experiences. These difficulties are sometimes referred to as personality difficulties and sometimes are diagnosed as a personality disorder. People with these problems often experience other common mental health problems such as depression and anxiety and seek help from primary care mental health  Improving Access to Psychological Therapy (IAPT) services. Screening tools show that many IAPT clients struggle with these additional difficulties, and research shows these clients have a poorer response to depression and anxiety treatments in IAPT. IAPT therapists are not routinely trained to tailor their treatment for people with these additional needs, and delivering training to improve therapist knowledge, skill and confidence to work with this group may lead to improvements in clinical outcomes. 

Who can participate?
IAPT services will be recruited to take part in the research, where all their ‘high intensity’ ‘Cognitive Behavioural’ Therapists (CBT) will be offered the opportunity to attend a training workshop focused on understanding and assessing personality difficulties and tailoring depression and anxiety treatments for those who can be safely treated in an IAPT setting.

What does the study involve?
We will measure a range of therapist outcomes before, after and 3 months after the training workshop, including their knowledge skill and confidence to work with this client group, and levels of well-being, burnout and presentee/absenteeism. We will also measure their feedback on the workshop itself. We will ask a small group of therapists to attend in-depth interviews to discuss their experiences and views on the workshop and any impacts on clinical practice. Services will introduce a brief screening tool for personality difficulties into their routine care during the study, and we will extract clinical outcomes for clients accessing treatment from participating in IAPT services in the 6 months before and after the workshop is delivered. This will enable us to understand if the workshop leads to any changes in clinical outcomes for clients with personality difficulties. 

What are the possible benefits and risks of participating?
There are no direct benefits to individual therapists for taking part in the research. Therapists participating in IAPT services will have the opportunity to attend the workshop regardless of whether they take part in the accompanying surveys and interviews. 

For staff attending the training intervention, while the training discusses some challenging material and work, we do not anticipate this, nor the linked surveys or interviews will result in any negative mood impact. Of 51 therapists who have already received this training, 48(94%) would recommend it to other therapists and 47 (92%) improved their knowledge, skills, and confidence working with this group. No attendees to date have reported an adverse reaction. The trainers are experienced therapists, have significant experience delivering similar training events to both IAPT staff and other clinicians, and have the necessary skills to manage any unintended negative mood impacts in participants should this arise as a result of the workshop.

A potential impact of the workshop on routine care not linked to direct participants:
It is also important to consider if training could lead to unintended iatrogenic outcomes for service users. Evidence to date suggests that this group of service users can and do benefit from IAPT treatments for depression and anxiety. The training focuses on upskilling therapists to make subtle adaptations to their usual practice to accommodate the additional difficulties this group may experience. It is well documented that individuals with additional or different needs may need subtle adaptations to best benefit from psychological treatments, and the IAPT Positive Practice Guide series offers guidance around reasonable adjustments for service users with Learning difficulties, from BAME backgrounds and with long-term health conditions (e.g. ("IAPT Learning Disabilities Positive Practice Guide," 2015)). Given a remote possibility of unintended iatrogenic outcomes for service users, upon the report of, or if evidence of trial- or intervention-related harms emerges through examining the qualitative and service-level outcome data, we will discuss with the trial team and consider stopping further sites (but not the ongoing evaluation of existing sites). 

Where is the study run from? 
Mood Disorder’s Centre, University of Exeter (UK)

When is the study starting and how long is it expected to run for?
October 2021 to March 2024

Who is funding the study?
The study is funded by the National Institute for Health and Care Research (NIHR) Three Schools Mental Health Fellowship Award, held by Laura Warbrick the Chief Investigator. The study will also receive support from some researchers who are funded by NIHR ARC West. 

Who is the main contact?
Laura Warbrick, l.a.warbrick@exeter.ac.uk</plainEnglishSummary>
      <primaryOutcomes/>
      <primaryOutcome>Primary outcome measures are feasibility and acceptability of training and treatment:
Recruitment:
1. Number of IAPT sites recruited, % of eligible therapists attending workshop, % of attending therapists completing pre-and post-surveys, % of attending therapists completing 3-month follow-up surveys

Acceptability: 
1. Clinical outcomes data completion (% clients receiving routine care during the study with sufficient data for inclusion in secondary analyses) measured using at least two occasions of a measure of depression (PHQ-9) and anxiety (GAD-7) symptoms, and at least one measure of personality difficulties (SAPAS-SR)
2. Proof of concept: 
2.1. Therapist attitudes measured using a bespoke attitudinal questionnaire (5 items on a 5-point Likert scale from strongly disagree to strongly agree) pre-, post- and 3-months after the training workshop
2.2. Quantitative workshop feedback measured using a bespoke 4-item questionnaire on a 5-point Likert scale from strongly disagree to strongly agree post-workshop</primaryOutcome>
      <secondaryOutcomes/>
      <secondaryOutcome>1. Therapist well-being measured using the adjusted short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) pre-, post- and 3-months after the training workshop
2. Therapist burnout measured using the Sussex Burnout Scale (SBS) measured pre-workshop at 3 months follow-up
3. Therapist presentee and absenteeism measured using the Presenteeism and Absenteeism questionnaire 3-item self-report questionnaire capturing the frequency of difficulties over the past month at pre-workshop and 3 months follow-up

4. Client clinical outcomes:
4.1. Depression symptoms measured using the Patient Health Questionnaire (PHQ-9) at the first and last treatment sessions
4.2. Anxiety symptoms measured using the Generalised Anxiety Disorder scale (GAD-7) at the first and last treatment sessions
4.3. Work and social functioning measured using the Work and Social Adjustment scale (WSAS) at the first and last treatment sessions
4.4. Personality difficulties measured using the Standardised Assessment of Personality – Abbreviated scale (self-report version) (SAPAS-SR) at the first treatment session/instance recorded in clinical notes</secondaryOutcome>
      <ethicsApprovalRequired>Old ethics approval format</ethicsApprovalRequired>
      <ethicsCommittees/>
      <ethicsApproval>Approved 19/10/2022, South Birmingham REC (Equinox House, City Link, Nottingham, NG2 4LA; +44 (0)207 104 8345; southbirmingham.rec@hra.nhs.uk), ref: 22/WM/0218</ethicsApproval>
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      <doi>10.1186/ISRCTN81104604</doi>
      <eudraCTNumber/>
      <irasNumber>312857</irasNumber>
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      <protocolSerialNumber>CPMS: 53996</protocolSerialNumber>
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    <trialDesign>
      <studyDesign>Psychological and behavioural complex intervention cohort study</studyDesign>
      <primaryStudyDesign>Interventional</primaryStudyDesign>
      <secondaryStudyDesign>Randomised controlled trial</secondaryStudyDesign>
      <trialTypes>
	<trialType>Treatment</trialType>
      </trialTypes>
      <overallEndDate>2024-03-31T00:00:00.000Z</overallEndDate>
    </trialDesign>
    <participants>
      <recruitmentCountries>
	<country>United Kingdom</country>
	<country>England</country>
      </recruitmentCountries>
      <trialCentres>
	<trialCentre id="063c6cff-f13e-496b-bc10-f402c007316f">
	  <name>Homerton University Hospital</name>
	  <address>Homerton Row</address>
	  <city>London</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>E9 6SR</zip>
	  <rtsId>RQXM1@2.16.840.1.113883.2.1.3.2.4.18.48</rtsId>
	</trialCentre>
	<trialCentre id="23d52a56-6341-43fa-853c-f846c96be153">
	  <name>St Georges Hospital</name>
	  <address>Corporation Street</address>
	  <city>Stafford</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>ST16 3SR</zip>
	</trialCentre>
	<trialCentre id="332b1315-5789-4e3f-8f17-41943b34838e">
	  <name>University of Exeter</name>
	  <address>Department of Psychology
Sir Henry Wellcome Building for Mood Disorders Research</address>
	  <city>Exeter</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>EX4 4QQ</zip>
	</trialCentre>
	<trialCentre id="d22d94d4-9691-444b-adfe-8e4f25a2098f">
	  <name>Kent and Medway Insight IAPT</name>
	  <address>2 Esh Plaza
Sir Bobby Robson Way</address>
	  <city>Newcastle upon Tyne</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>NE13 9BA</zip>
	</trialCentre>
	<trialCentre id="d2d28b7e-9a0b-42e3-b813-5149ff2d092c">
	  <name>Nottinghamshire Insight IAPT</name>
	  <address>2 Esh Plaza
Sir Bobby Robson Way</address>
	  <city>Newcastle upon Tyne</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>NE13 9BA</zip>
	</trialCentre>
      </trialCentres>
      <participantTypes>
	<participantType>Patient</participantType>
      </participantTypes>
      <inclusion>1. UK IAPT services
2. Therapists: High intensity Cognitive Behavioural therapists working within a participating IAPT service, who plan to attend the training workshop
3. Service level outcomes will be examined based on all clients accessing the service during the research study (6 months prior to and post-therapist training), and focusing on those with scores indicating personality difficulties  (i.e. 9 and above on the PDS-IC-11 and/or 3 and above on the SAPAS*)

Subject to necessary Copywrite permissions. If Permissions cannot be obtained prior to study commencement, services will collect just the PDS-ICD-11.</inclusion>
      <ageRange>Adult</ageRange>
      <gender>All</gender>
      <targetEnrolment>120</targetEnrolment>
      <totalFinalEnrolment/>
      <exclusion>1. IAPT services will be excluded if they are unable to implement a measure of personality disturbance as a measure routinely collected at the assessment and treatment end
2. Therapists will be excluded if they do not subsequently take part in the training</exclusion>
      <recruitmentStart>2023-03-01T00:00:00.000Z</recruitmentStart>
      <recruitmentEnd>2023-10-31T00:00:00.000Z</recruitmentEnd>
      <recruitmentStartStatusOverride/>
      <recruitmentStatusOverride/>
    </participants>
    <conditions>
      <condition>
	<description>Mental health</description>
	<diseaseClass1>Mental and Behavioural Disorders</diseaseClass1>
	<diseaseClass2/>
      </condition>
    </conditions>
    <interventions>
      <intervention>
	<description>DESIGN: 
This study is a multi-site mixed-methods evaluation and intervention development project of a new training initiative for IAPT high-intensity therapists focusing on adapting usual practice to accommodate secondary personality difficulties alongside a primary problem of depression and/or an anxiety disorder. 
A single-site pilot evaluation, which just captures a subset of outcomes and is not formally a priori powered to detect therapist attitudinal change is being conducted in a non-NHS site with non-NHS therapists to preliminarily explore the acceptability and effectiveness of the current version of the training. Feedback from this will be used to refine the training approach before running the present research described here. This pilot site has already been approved under a separate ethics application (IRAS 303144).

SAMPLE 
This evaluation will take place within three diverse Improving Access to Psychological Therapies (IAPT) sites (chosen to differ in terms of geographical area and service-user socio-economic status and ethnicity). 
The present study will evaluate the refined training using a pre-post cohort design to examine if training led to changes in therapist attitudes, perceived capability, wellbeing, burnout, or presenteeism/absenteeism and will explore the acceptability and perceived usefulness of training to IAPT therapists. Qualitative analyses will also aim to understand the implementation and usefulness of the training to IAPT therapists using normalization process theory (NPT). 
Therapist data will be captured within three surveys: pre- and post-training and at 3-months follow-up. The pre-training survey will consist of basic demographic information (Age range, gender, ethnicity, experience level); bespoke Likert scale questions exploring attitudes and beliefs about working with clients with personality difficulties; the Sussex burnout scale, a brief measure of well-being (SWEMWBS); and questions capturing self-reported presenteeism and absenteeism. 
The post-training survey will be sent out immediately after the training. This will consist of bespoke Likert scale questions exploring attitudes and beliefs about working with clients with personality difficulties, Likert scale and open-answer questions capturing views on the workshop, and open-answer questions about the impact of training workshops, such as the one they just attended on their wellbeing. 
The 3-month follow-up questionnaire will be sent out 3 months after the training intervention. This will include a brief measure of well-being (SWEMWBS); the Sussex burnout scale; questions capturing self-reported presenteeism and absenteeism; and written qualitative questions about the impact of the training on own well-being and own work. 
Approximately one month after the workshop, a subset of the therapist participants will be invited to attend qualitative interviews. This initial invitation will be made by email and potential therapist interview participants will be given a participant information sheet about the interviews. Two further email reminders will be sent at approximately 2-weekly intervals following the initial invitation. Potential interview participants will be asked to respond directly to the researcher if they are interested in taking part. 
We will also examine preliminary proof-of-concept that training improves service-level outcomes. For this, we will extract and examine routine clinical outcomes and routinely collected Patient Experience Questionnaires (PEQ) relating to individuals accessing care during 6-months pre- and post-training cohorts.</description>
	<interventionType>Behavioural</interventionType>
	<phase/>
	<drugNames/>
      </intervention>
    </interventions>
    <results>
      <ipdSharingStatement>The datasets generated during and/or analysed during the current study are/will be available upon request from Laura Warbrick, l.a.warbrick@exeter.ac.uk. This study will generate two types of data:
1. Raw therapist data:
Any requests for sharing of the anonymised dataset for future research will be screened by the University of Exeter prior to any sharing and may require a Data Sharing Agreement to be in place. This will include data from only those participants who consented for their data to be shared for use in future research.
2. Secondary, anonymised client routine outcome data:
By default, this data will not be shared with any other parties beyond the immediate research team without first seeking prior approval from both the University sponsor and the NHS/HSC organisations.</ipdSharingStatement>
      <dataPolicies>
	<dataPolicy>Available on request</dataPolicy>
      </dataPolicies>
      <publicationDetails>2023 Protocol article in https://doi.org/10.1186/s40814-023-01394-z (added 06/10/2023)</publicationDetails>
      <publicationStage>Protocol</publicationStage>
      <basicReport/>
      <plainEnglishReport/>
    </results>
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    <forename>Laura</forename>
    <surname>Warbrick</surname>
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      <address>Sir Henry Wellcome Building for Mood Disorders Research
University of Exeter
Perry Road</address>
      <city>Exeter</city>
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  <trial lastUpdated="2023-01-11T12:34:57.659246Z" version="86" isPublished="true" publicIdentifierType="isrctn" publicIdentifierCanonical="ISRCTN30005319" publicIdentifierDateAssigned="2017-06-16T11:22:33.086Z">
    <isrctn dateAssigned="2017-06-16T11:22:33.086Z">30005319</isrctn>
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      <acknowledgment>true</acknowledgment>
      <title>Does using Endocuff Vision device increase the ability to find bowel polyps in bowel cancer screening endoscopy?</title>
      <scientificTitle>The B-ADENOMA Study: Bowel Scope - Accuracy of Detection using ENdocuff Optimisation of Mucosal Abnormalities</scientificTitle>
      <acronym>B-ADENOMA</acronym>
      <studyHypothesis>The aim of this study is to evaluate the effectiveness of using Endocuff Vision in detecting colonic adenomas (polyps in the bowel which may progress to bowel cancer), making sure the procedure is the same or better than the current procedure in all other aspects.</studyHypothesis>
      <plainEnglishSummary>https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-device-that-may-help-find-manage-polyps-bowel-during-cancer-screening-test-b-adenoma</plainEnglishSummary>
      <primaryOutcomes/>
      <primaryOutcome>Adenoma detection rate (ADR) is measured by histological examination of polyps, recorded 14 days after the procedure</primaryOutcome>
      <secondaryOutcomes/>
      <secondaryOutcome>1. Mean adenomas detected per procedure are measured by histological examination of polyps, at 14 days after the procedure
2. Rate of cuff exchange (that is, how often the cuff has to be removed) at the time of the procedure
3. Complete withdrawal time in procedures where no polyps are detected, measured using withdrawal times at the time of the procedure
4. Overall procedure time is measured at time of procedure
5. ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation), recorded at the time of the procedure
6. Rate of discovered cancers is measured by histological examination of biopsies/polyps, recorded up to 14 days after the procedure
7. Examination extent is measured using anatomical assessment of and distance (in centimetres) of intubation at the time of the procedure
8. Patient satisfaction is measured using the modified Gloucester scale of assessment of patient comfort at day of procedure and 24 hours after
9. Differences in future colonoscopic workload produced by increased ADR is measured using the change in the number of patients referred for full colonoscopy at day of the procedure 
10. Changes in ADR to assess any learning curve effect is measured using primary outcome data for the first and last 20% of cases per individual colonoscopist after recruitment has completed
11. ADR of each colonoscopist prior to trial recruitment compared with their individual ADR in patients where EndocuffTM Vision was not used is measured using data from the Bowel Cancer Screening programme collected pre-trial and after the trial has completed recruitment from primary outcome data</secondaryOutcome>
      <ethicsApprovalRequired>Old ethics approval format</ethicsApprovalRequired>
      <ethicsCommittees/>
      <ethicsApproval>West Midlands Research Ethics Committee - Solihull, 20/01/2017, ref: 16/WM/0514</ethicsApproval>
    </trialDescription>
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      <doi>10.1186/ISRCTN30005319</doi>
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      <irasNumber/>
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      <protocolSerialNumber>33224</protocolSerialNumber>
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    <trialDesign>
      <studyDesign>Randomised; Interventional; Design type: Screening, Diagnosis, Prevention, Device</studyDesign>
      <primaryStudyDesign>Interventional</primaryStudyDesign>
      <secondaryStudyDesign>Randomised controlled trial</secondaryStudyDesign>
      <trialTypes>
	<trialType>Treatment</trialType>
      </trialTypes>
      <overallEndDate>2018-08-30T00:00:00.000Z</overallEndDate>
    </trialDesign>
    <participants>
      <recruitmentCountries>
	<country>United Kingdom</country>
	<country>England</country>
      </recruitmentCountries>
      <trialCentres>
	<trialCentre id="0519d13a-8fc3-4863-a978-19b25a0dbd10">
	  <name>South Tyneside District Hospital (Lead Centre)</name>
	  <address>Harton Lane
Tyne and Wear</address>
	  <city>South Shields</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>NE34 0PL</zip>
	</trialCentre>
	<trialCentre id="62e3a04c-2e9c-44ab-a088-01fd34b8f87f">
	  <name>St. Mark’s Hospital</name>
	  <address>Watford Road</address>
	  <city>Middlesex</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>HA1 3UJ</zip>
	</trialCentre>
	<trialCentre id="8dcefb11-90a7-4196-8217-8e7922aa2adc">
	  <name>Queen Alexandra Hospital</name>
	  <address>Southwick Hill Road</address>
	  <city>Cosham</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>PO6 3LY</zip>
	</trialCentre>
	<trialCentre id="59e3a701-f310-44fb-90fb-6885229bdb8b">
	  <name>University Hospital North Tees</name>
	  <address>Hardwick Road
Hardwick</address>
	  <city>Stockton-on-Tees</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>TS19 8PE</zip>
	</trialCentre>
	<trialCentre id="83eb54fb-fec3-4f57-a15d-d0f929ab0369">
	  <name>Bishop Auckland Hospital</name>
	  <address>Cockton Hill Road</address>
	  <city>Bishop Auckland</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>DL14 6AD</zip>
	</trialCentre>
	<trialCentre id="0ddb9022-6cbd-4e6b-823f-df805194740b">
	  <name>North Tyneside General Hospital</name>
	  <address>Rake Lane</address>
	  <city>North Shields</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>NE29 8NH</zip>
	</trialCentre>
	<trialCentre id="41bde209-5409-47e6-b8e5-de71fe24f7e5">
	  <name>Queen Elizabeth Hospital</name>
	  <address>Queen Elizabeth Avenue</address>
	  <city>Gateshead</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>NE9 6SX</zip>
	</trialCentre>
	<trialCentre id="714ea8f3-3ade-42cf-96d7-6847b9a89879">
	  <name>Northern General Hospital</name>
	  <address>Herries Road</address>
	  <city>Sheffield</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>S5 7AU</zip>
	</trialCentre>
	<trialCentre id="23bfb9b8-f6de-4103-9d85-7fc0b289b961">
	  <name>Fairfield General Hospital</name>
	  <address>Rochdale Old Road</address>
	  <city>Bury</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>BL9 7TD</zip>
	</trialCentre>
	<trialCentre id="e07f1a16-5352-43d6-83a7-f38aa02263b4">
	  <name>Gloucestershire Royal Hospital</name>
	  <address>Great Western Road</address>
	  <city>Gloucester</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>GL1 3NN</zip>
	</trialCentre>
	<trialCentre id="5b5a30ac-2c29-4e82-acb7-be430c4a38e8">
	  <name>New Cross Hospital</name>
	  <address>Wolverhampton Road
Heath Town</address>
	  <city>Wolverhampton</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>WV10 0QP</zip>
	</trialCentre>
	<trialCentre id="f349427b-d7b6-4462-9b19-1146b422a06d">
	  <name>Royal Bolton Hospital</name>
	  <address>Minerva Road
Farnworth</address>
	  <city>Bolton</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>BL4 0JR</zip>
	</trialCentre>
	<trialCentre id="50535732-bd67-4a9e-a6f8-af5ca3f9cf24">
	  <name>The Whittington Hospital</name>
	  <address>Magdala Avenue</address>
	  <city>London</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>N19 5NF</zip>
	</trialCentre>
	<trialCentre id="54a3a58a-722d-4b5f-8289-ab7efcf6b8f6">
	  <name>Kettering General Hospital</name>
	  <address>Rothwell Road</address>
	  <city>Kettering</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>N19 5NF</zip>
	</trialCentre>
	<trialCentre id="3471461c-6af6-4a03-8305-59c36256984b">
	  <name>John Radcliffe Hospital</name>
	  <address>Headley Way
Headington</address>
	  <city>Oxford</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>OX3 9DU</zip>
	</trialCentre>
	<trialCentre id="e60ef4d8-6459-4afe-a7e1-481deb433591">
	  <name>University College Hospital</name>
	  <address>235 Euston Road
Bloomsbury</address>
	  <city>London</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>NW1 2BU</zip>
	</trialCentre>
	<trialCentre id="64a2f55f-5c47-498b-a416-f2b5947a1376">
	  <name>Charing Cross Hospital</name>
	  <address>Fulham Palace Road</address>
	  <city>London</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>W6 8RF</zip>
	</trialCentre>
	<trialCentre id="b8129425-7912-433b-976c-38f56a5af62d">
	  <name>Royal Lancaster Infirmary</name>
	  <address>Ashton Road</address>
	  <city>Lancaster</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>LA1 4RP</zip>
	</trialCentre>
	<trialCentre id="e1eb1dd6-bd18-4c66-ac4a-db586369623d">
	  <name>Addenbrooke’s Hospital</name>
	  <address>Hills Road</address>
	  <city>Cambridge</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>CB2 0QQ</zip>
	</trialCentre>
	<trialCentre id="265edd0b-e043-4bb9-a4ef-bff7f915d947">
	  <name>Dorset County Hospital</name>
	  <address>Williams Avenue</address>
	  <city>Dorchester</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>DT1 2JY</zip>
	</trialCentre>
	<trialCentre id="27a8b538-b684-47fe-8c32-74b8ce5b09ed">
	  <name>Watford General Hospital</name>
	  <address>Vicarage Road</address>
	  <city>Watford</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>WD18 0HB</zip>
	</trialCentre>
      </trialCentres>
      <participantTypes>
	<participantType>Patient</participantType>
      </participantTypes>
      <inclusion>1. Age 55 to 61 years (both male and female)
2. Referral for screening flexible sigmoidoscopy
3. Ability to give informed consent</inclusion>
      <ageRange>Adult</ageRange>
      <gender>All</gender>
      <targetEnrolment>3222</targetEnrolment>
      <totalFinalEnrolment>3222</totalFinalEnrolment>
      <exclusion>1. Absolute contraindications to flexible sigmoidoscopy 
2. Established or suspicion of large bowel obstruction or pseudo-obstruction 
3. Known colon cancer or polyposis syndromes
4. Known colonic strictures
5. Known severe diverticular segment (that is likely to impede sigmoidoscope passage)
6. Patients with active colitis (ulcerative colitis, Crohn’s colitis, diverticulitis, infective colitis)
7. Patients lacking capacity to give informed consent
8. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure  
9. Pregnancy</exclusion>
      <recruitmentStart>2017-02-14T00:00:00.000Z</recruitmentStart>
      <recruitmentEnd>2018-02-13T00:00:00.000Z</recruitmentEnd>
      <recruitmentStartStatusOverride/>
      <recruitmentStatusOverride/>
    </participants>
    <conditions>
      <condition>
	<description>Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs, Oral and Gastrointestinal/ Other diseases of the digestive system</description>
	<diseaseClass1>Digestive System</diseaseClass1>
	<diseaseClass2>Malignant neoplasms of digestive organs</diseaseClass2>
      </condition>
    </conditions>
    <interventions>
      <intervention>
	<description>Participants undergo a endoscopy as per usual practice. Participants are randomly allocated to one of the groups using randomisation software, stratifying for age group and gender.

Treatment arm: Participants in this arm have the Endocuff Vision mounted on the endoscope for the one-off flexible sigmoidoscopy. 

Control arm: The one-off flexible sigmoidoscopy is completed as normal, without the Endocuff Vision on the scope.

Participants are followed up for 14 days after the test test to ensure there are no adverse events.</description>
	<interventionType>Other</interventionType>
	<phase/>
	<drugNames/>
      </intervention>
    </interventions>
    <results>
      <ipdSharingStatement>The datasets generated during and/or analysed during the current study is not expected to be made available due to no specific patient consent being given for this.</ipdSharingStatement>
      <dataPolicies>
	<dataPolicy>Not expected to be made available</dataPolicy>
      </dataPolicies>
      <publicationDetails>2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32245908/ results (added 26/11/2020)</publicationDetails>
      <publicationStage>Results</publicationStage>
      <basicReport/>
      <plainEnglishReport/>
    </results>
    <outputs>
      <output id="9f09553d-d002-49a7-a667-84332cc61ac5" outputType="resultsarticle" artefactType="ExternalLink" dateCreated="2020-11-01T00:00:00.000Z" dateUploaded="2020-11-26T00:00:00.000Z" peerReviewed="true" patientFacing="false" createdBy="Data migration">
	<externalLink url="https://pubmed.ncbi.nlm.nih.gov/32245908/"/>
	<description>results</description>
	<productionNotes/>
      </output>
      <output id="5ac3a8c1-d15e-491f-8e53-0b4be794d566" outputType="hrasummary" artefactType="ExternalLink" dateCreated="" dateUploaded="2023-06-28T00:00:00.000Z" peerReviewed="false" patientFacing="false" createdBy="System">
	<externalLink url="https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/the-b-adenoma-study/"/>
	<description/>
	<productionNotes>Added from spreadsheet</productionNotes>
      </output>
    </outputs>
    <parties xmlns:ssb="http://www.67bricks.com/isrctn/functions">
      <funderId>59f089b0-c691-4bc9-a5a2-03821b2a912c</funderId>
      <funderId>6bd288e1-bd36-44d2-b6ae-3f8da52ebe61</funderId>
      <contactId>9663083c-5cea-4946-bb61-6e36c911a764</contactId>
      <sponsorId>356c90b6-8acf-4413-9318-d8f520370bb0</sponsorId>
    </parties>
    <miscellaneous xmlns:ssb="http://www.67bricks.com/isrctn/functions">
      <ipdSharingPlan>No</ipdSharingPlan>
    </miscellaneous>
    <attachedFiles/>
  </trial>
  <contact id="9663083c-5cea-4946-bb61-6e36c911a764">
    <title>Mr</title>
    <forename>Martin</forename>
    <surname>Walls</surname>
    <orcid/>
    <contactTypes>
      <contactType>Public</contactType>
    </contactTypes>
    <contactDetails>
      <address>South Tyneside District Hospital
Harton Lane
South Shields
Tyne and Wear</address>
      <city>South Shields</city>
      <state/>
      <country>United Kingdom</country>
      <zip>NE34 0PL</zip>
      <telephone xmlns:ssb="http://www.67bricks.com/isrctn/functions"/>
      <email xmlns:ssb="http://www.67bricks.com/isrctn/functions"/>
    </contactDetails>
    <privacy>Protected</privacy>
  </contact>
  <sponsor id="356c90b6-8acf-4413-9318-d8f520370bb0">
    <organisation>South Tyneside District Hospital</organisation>
    <sponsorType>Hospital/treatment centre</sponsorType>
    <rorId>https://ror.org/00q75av54</rorId>
    <commercialStatus>Non-commercial</commercialStatus>
  </sponsor>
  <funder id="59f089b0-c691-4bc9-a5a2-03821b2a912c">
    <name>Arc Medical Design Limited</name>
  </funder>
  <funder id="6bd288e1-bd36-44d2-b6ae-3f8da52ebe61">
    <name>Norgine Limited</name>
  </funder>
</fullTrial><fullTrial>
  <trial lastUpdated="2025-01-15T16:39:44.298635Z" version="52" isPublished="true" publicIdentifierType="isrctn" publicIdentifierCanonical="ISRCTN12951626" publicIdentifierDateAssigned="2015-07-16T10:42:50.260Z">
    <isrctn dateAssigned="2015-07-16T10:42:50.260Z">12951626</isrctn>
    <trialDescription thirdPartyFilesAcknowledgement="false">
      <acknowledgment>true</acknowledgment>
      <title>Tennis elbow platelet-rich plasma injection study</title>
      <scientificTitle>A pilot study of platelet-rich plasma (PRP) versus autologous whole blood versus saline in the treatment of resistant tennis elbow</scientificTitle>
      <acronym>TEPIS</acronym>
      <studyHypothesis>The primary aim of this study is to assess feasibility and guide the planning of a large multi-centre study to investigate both the clinical and cost effectiveness of platelet-rich plasma (PRP) as a treatment for tennis elbow. Three treatment options will be investigated; an injection of either whole blood, PRP or saline using a technique called needle barbotage that disrupts tendon fibres and promotes the healing process. Patients will be allocated to one of the treatment groups at random.</studyHypothesis>
      <plainEnglishSummary>Background and study aims 
Tennis elbow is a common condition that causes lateral elbow pain. It is associated with repetitive activity at work and play and is thought to be caused by micro-tears in the tendons of the elbow. Although many cases resolve over a period of 3 months, either with or without non-surgical treatments such as rest, exercises and bracing, other treatments may be necessary such as corticosteroid injections or surgery. In an autologous blood injection, blood is taken from the patient and re-injected around the affected tendon. Either whole blood can be injected, or a fragment known as platelet-rich plasma (PRP) can be separated from the red blood cells and injected. PRP contains a high level of growth factors which are thought to stimulate the healing process. The primary aim of this study is to assess feasibility and guide the planning of a large multi-centre study to investigate both the clinical and cost effectiveness of PRP as a treatment for tennis elbow. Three treatment options will be investigated; an injection of either whole blood, PRP or saline using a technique called needle barbotage that disrupts tendon fibres and promotes the healing process.

Who can participate? 
Patients aged between 18-65 attending Robert Jones and Agnes Hunt Orthopaedic Hospital with symptoms of Tennis Elbow.

What does the study involve? 
Participants are allocated to one of three groups at random. Those in group 1 are given a whole blood injection. Those in group 2 are given PRP. Those in group 3 are given saline. Assessments of pain and elbow function are carried out at 6 weeks, 12 weeks, 6 months and 1 year.

What are the possible benefits and risks of participating? 
Not provided at time of registration

Where is the study run from? 
March 2015 to April 2016

When is the study starting and how long is it expected to run for? 
Robert Jones &amp; Agnes Hunt Orthopaedic &amp; District Hospital, Oswestry (UK)

Who is funding the study? 
The British Elbow &amp; Shoulder Society (BESS), Lavender Medical and The Orthopaedic Institute Limited.

Who is the main contact? 
Dr Johanna Wales</plainEnglishSummary>
      <primaryOutcomes/>
      <primaryOutcome>Patient rated tennis elbow evaluation (PRTEE); Timepoint(s): 12 weeks post-injection</primaryOutcome>
      <secondaryOutcomes/>
      <secondaryOutcome>1. Adverse events; Timepoint(s): peri-procedural, 6 weeks, 12 weeks, 6 months and 12 months
2. Disabilities of the arm, shoulder and hand (DASH) questionnaire; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months
3. EQ-5D; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months
4. Health economic data (resourse usage); Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months; 5. Loss to follow-up and withdrawal rates; Timepoint(s): 12 months
6. Mayo elbow performance indicator (MEPI); Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months; Recruitment rate; Timepoint(s): 12 months
7.  Visual analogue pain score; Timepoint(s): 6 weeks, 12 weeks, 6 months and 12 months</secondaryOutcome>
      <ethicsApprovalRequired>Old ethics approval format</ethicsApprovalRequired>
      <ethicsCommittees/>
      <ethicsApproval>First MREC approval date 22/08/2014, ref: 14/WM/1063;</ethicsApproval>
    </trialDescription>
    <externalRefs>
      <doi>10.1186/ISRCTN12951626</doi>
      <eudraCTNumber/>
      <irasNumber/>
      <clinicalTrialsGovNumber/>
      <protocolSerialNumber>17180</protocolSerialNumber>
      <secondaryNumbers>
	<secondaryNumber id="b2ae0d1f-3f72-4b46-a8a7-4208f9d320c5" numberType="Protocol serial number">17180</secondaryNumber>
      </secondaryNumbers>
    </externalRefs>
    <trialDesign>
      <studyDesign>Randomized; Interventional; Design type: Treatment</studyDesign>
      <primaryStudyDesign>Interventional</primaryStudyDesign>
      <secondaryStudyDesign>Randomised controlled trial</secondaryStudyDesign>
      <trialTypes>
	<trialType>Treatment</trialType>
      </trialTypes>
      <overallStatusOverride>Stopped</overallStatusOverride>
      <reasonAbandoned>Objectives no longer viable</reasonAbandoned>
      <overallEndDate>2021-03-17T00:00:00.000Z</overallEndDate>
    </trialDesign>
    <participants>
      <recruitmentCountries>
	<country>United Kingdom</country>
	<country>England</country>
      </recruitmentCountries>
      <trialCentres>
	<trialCentre id="2e65cce2-caa7-4fec-b6c9-3d6d691403a6">
	  <name>Robert Jones &amp; Agnes Hunt Orthopaedic &amp; District Hospital</name>
	  <address>ARC Building
Twmpath Lane</address>
	  <city>Oswestry</city>
	  <state/>
	  <country>United Kingdom</country>
	  <zip>SY10 7AG</zip>
	</trialCentre>
      </trialCentres>
      <participantTypes>
	<participantType>Patient</participantType>
      </participantTypes>
      <inclusion>1. Established lateral epicondyle tendinopathy with a minimum symptom duration of 3 months
2. Aged 18 years or above and below 65 years
3. Willing to avoid the use of topical and oral nonsteroidal anti-inflammatory drugs for a period of 6 weeks following injection
4. Has completed the study physiotherapy program for a minimum period of 6 weeks with no improvement in symptoms
Target Gender: Male &amp; Female; Upper Age Limit 65 years ; Lower Age Limit 18 years</inclusion>
      <ageRange>Adult</ageRange>
      <lowerAgeLimit unit="years" value="18.0">18 Years</lowerAgeLimit>
      <upperAgeLimit unit="years" value="65.0">65 Years</upperAgeLimit>
      <gender>All</gender>
      <targetEnrolment>30</targetEnrolment>
      <totalFinalEnrolment>29</totalFinalEnrolment>
      <exclusion>1. Bilateral tennis elbow
2. Currently taking part in any interventional study that may impact upon study outcomes.
3. A concomitant injury that may impact on the ability to complete outcome assessments
4. Previous surgical intervention of the tendinopathy
5. Inflammatory disease, or chronic widespread pain syndrome
6. Requires regular use of anti-inflammatory medication for complaints other than Tennis Elbow
7. Known platelet dysfunction or thrombocytopaenia, or haemodynamic instability
8. Malignancy
9. Unable or unwilling to complete the 12 month follow-up assessments
10. Unable to communicate fluently in English or an inability to respond to validated questionnaires written in the English language
11. Platelet count &lt;105/microlitre
12. Corticosteroid injection at the treatment site within the last 4 weeks, or systemic use of corticosteroids within the last 2 weeks. Anti-coagulation therapy within 5 days before treatment
13. Treatment with Non-steroidal anti-inflammatory drugs within 1 week prior to treatment
14. Septicaemia or fever</exclusion>
      <recruitmentStart>2015-03-09T00:00:00.000Z</recruitmentStart>
      <recruitmentEnd>2016-04-01T00:00:00.000Z</recruitmentEnd>
      <recruitmentStartStatusOverride/>
      <recruitmentStatusOverride/>
    </participants>
    <conditions>
      <condition>
	<description>Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal</description>
	<diseaseClass1>Musculoskeletal Diseases</diseaseClass1>
	<diseaseClass2>Lateral epicondylitis</diseaseClass2>
      </condition>
    </conditions>
    <interventions>
      <intervention>
	<description>Injection of either whole blood, platelet-rich plasma or saline using a technique called needle barbotage that disrupts tendon fibres and promotes the healing process
Follow Up Length: 12 month(s)</description>
	<interventionType>Biological/Vaccine</interventionType>
	<phase>Not Applicable</phase>
	<drugNames>Platelet-rich plasma injection</drugNames>
      </intervention>
    </interventions>
    <results>
      <ipdSharingStatement/>
      <dataPolicies>
	<dataPolicy>Not provided at time of registration</dataPolicy>
      </dataPolicies>
      <publicationDetails/>
      <publicationStage/>
      <basicReport/>
      <plainEnglishReport/>
    </results>
    <outputs>
      <output id="c4cd5c7c-21ae-4f3d-bc58-8bf3dd0d7711" outputType="hrasummary" artefactType="ExternalLink" dateCreated="" dateUploaded="2023-07-26T00:00:00.000Z" peerReviewed="false" patientFacing="false" createdBy="System">
	<externalLink url="https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/tennis-elbow-platelet-rich-plasma-injection-study-tepis/"/>
	<description/>
	<productionNotes>Added from spreadsheet</productionNotes>
      </output>
    </outputs>
    <parties xmlns:ssb="http://www.67bricks.com/isrctn/functions">
      <funderId>234c46e2-0877-4a48-a32a-e4e53ea6b47c</funderId>
      <funderId>698b4330-518a-4bfe-8628-da9b9d797d2e</funderId>
      <funderId>b6d24867-dd17-48b7-9dbe-0f279fd9a595</funderId>
      <contactId>f5852767-9152-4e57-ad22-221b38f99e17</contactId>
      <sponsorId>aee4379d-7767-4ee0-a8f8-12fa360123d0</sponsorId>
    </parties>
    <miscellaneous xmlns:ssb="http://www.67bricks.com/isrctn/functions">
      <ipdSharingPlan>No</ipdSharingPlan>
    </miscellaneous>
    <attachedFiles/>
  </trial>
  <contact id="f5852767-9152-4e57-ad22-221b38f99e17">
    <title>Dr</title>
    <forename>Johanna</forename>
    <surname>Wales</surname>
    <orcid/>
    <contactTypes>
      <contactType>Public</contactType>
    </contactTypes>
    <contactDetails>
      <address>Robert Jones &amp; Agnes Hunt Orthopaedic &amp; District Hospital
ARC Building
Twmpath Lane</address>
      <city>Oswestry</city>
      <state/>
      <country>United Kingdom</country>
      <zip>SY10 7AG</zip>
      <telephone xmlns:ssb="http://www.67bricks.com/isrctn/functions"/>
      <email xmlns:ssb="http://www.67bricks.com/isrctn/functions"/>
    </contactDetails>
    <privacy>Protected</privacy>
  </contact>
  <sponsor id="aee4379d-7767-4ee0-a8f8-12fa360123d0">
    <organisation>The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust</organisation>
    <sponsorType>Hospital/treatment centre</sponsorType>
    <rorId>https://ror.org/030mbcp39</rorId>
    <commercialStatus>Non-commercial</commercialStatus>
  </sponsor>
  <funder id="234c46e2-0877-4a48-a32a-e4e53ea6b47c">
    <name>British Elbow &amp; Shoulder Society (BESS)</name>
  </funder>
  <funder id="698b4330-518a-4bfe-8628-da9b9d797d2e">
    <name>Lavender Medical</name>
  </funder>
  <funder id="b6d24867-dd17-48b7-9dbe-0f279fd9a595">
    <name>The Orthopaedic Institute Limited</name>
  </funder>
</fullTrial></allTrials>