Condition category
Digestive System
Date applied
12/06/2017
Date assigned
16/06/2017
Last edited
11/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

N/A

Contact information

Type

Public

Primary contact

Mr Martin Walls

ORCID ID

Contact details

South Tyneside District Hospital
Harton Lane
South Shields
Tyne and Wear
South Shields
NE34 0PL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33224

Study information

Scientific title

The B-ADENOMA Study: Bowel Scope - Accuracy of Detection using ENdocuff Optimisation of Mucosal Abnormalities

Acronym

B-ADENOMA

Study hypothesis

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.

Ethics approval

West Midlands Research Ethics Committe - Solihull, 20/01/2017, ref: 16/WM/0514

Study design

Randomised; Interventional; Design type: Screening, Diagnosis, Prevention, Device

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs, Oral and Gastrointestinal/ Other diseases of the digestive system

Intervention

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.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Adenoma detection rate (ADR) is measured by histological examination of polyps, recorded 14 days after the procedure

Secondary outcome measures

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

Overall trial start date

17/03/2016

Overall trial end date

01/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 55 to 61 years (both male and female)
2. Referral for screening flexible sigmoidoscopy
3. Ability to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 3222; UK Sample Size: 3222

Participant exclusion criteria

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

Recruitment start date

14/02/2017

Recruitment end date

01/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Tyneside District Hospital (Lead Centre)
Harton Lane Tyne and Wear
South Shields
NE34 0PL
United Kingdom

Trial participating centre

St. Mark’s Hospital
Watford Road
Middlesex
HA1 3UJ
United Kingdom

Trial participating centre

Queen Alexandra Hospital
Southwick Hill Road
Cosham
PO6 3LY
United Kingdom

Trial participating centre

University Hospital North Tees
Hardwick Road Hardwick
Stockton-on-Tees
TS19 8PE
United Kingdom

Trial participating centre

Bishop Auckland Hospital
Cockton Hill Road
Bishop Auckland
DL14 6AD
United Kingdom

Trial participating centre

North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH

Trial participating centre

Queen Elizabeth Hospital
Queen Elizabeth Avenue
Gateshead
NE9 6SX

Trial participating centre

Northern General Hospital
Herries Road
Sheffield
S5 7AU

Trial participating centre

Fairfield General Hospital
Rochdale Old Road
Bury
BL9 7TD

Trial participating centre

Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN

Trial participating centre

New Cross Hospital
Wolverhampton Road Heath Town
Wolverhampton
WV10 0QP

Trial participating centre

Royal Bolton Hospital
Minerva Road Farnworth
Bolton
BL4 0JR

Trial participating centre

The Whittington Hospital
Magdala Avenue
London
N19 5NF

Trial participating centre

Kettering General Hospital
Rothwell Road
Kettering
N19 5NF

Trial participating centre

John Radcliffe Hospital
Headley Way Headington
Oxford
OX3 9DU

Trial participating centre

University College Hospital
235 Euston Road Bloomsbury
London
NW1 2BU

Trial participating centre

Charing Cross Hospital
Fulham Palace Road
London
W6 8RF

Trial participating centre

Royal Lancaster Infirmary
Ashton Road
Lancaster
LA1 4RP

Trial participating centre

Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ

Trial participating centre

Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY

Trial participating centre

Watford General Hospital
Vicarage Road
Watford
WD18 0HB

Sponsor information

Organisation

South Tyneside District Hospital

Sponsor details

South Tyneside NHS Foundation Trust
Harton Lane
South Shields
NE34 0PL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Arc Medical Design Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Norgine Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal by October 2019. International presentation at UEGW and BSG annual meetings. Presentation to BSG Endoscopy Research Committee and BCSP

IPD sharing statement:
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.

Intention to publish date

31/10/2019

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/08/2017: Internal review.