Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02552017
Protocol/serial number
v 5.0, 07.08.2014
Study information
Scientific title
Accuracy of Detection using ENdocuff Optimisation of Mucosal Abnormalities
Acronym
ADENOMA
Study hypothesis
It is predicted that using the Endocuff Vision will improve the adenoma detection rate.
Primary objective:
1. To detect a difference in adenoma detection rate between Endocuff-Assisted Colonoscopy (EAC) and Standard Colonoscopy (SC)
Secondary objectives:
1. To detect a difference in mean adenomas detected per procedure (MAP2) between EAC and SC
2. To establish the rate of cuff exchange (that is, how often the cuff has to be removed)
3. To demonstrate non-inferiority of caecal intubation rates and insertion time to caecum between EAC and SC
4. To demonstrate non-inferiority in complete withdrawal time in procedures where no polyps are detected between EAC and SC
5. To demonstrate non-inferiority of patient satisfaction with EAC compared to SC
6. To identify any difference in future colonoscopic workload produced by increased ADR in terms of number of potential follow-up procedures based on BSG adenoma surveillance guidelines between the EAC and SC groups
These outcomes will be analysed on an intention-to-treat basis.
Ethics approval
NRES Committee North East - York. REC, ref. 14/NE/1111 - review date 12/09/2014
Study design
Multicentre prospective randomised controlled interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Conditions requiring colonoscopy assessment, colonic adenomas
Intervention
Two study arms:
1. Control arm - routine colonoscopy performed in standard fashion with no Endocuff Vision attached to scope
2. Intervention arm - colonoscopy performed with Endocuff Vision device attached to end of colonoscope
Intervention will be for the duration of the colonoscopy only. Participants will also complete a patient experience questionnaire immediately after, and within a week after, the procedure. Histology results of any polyps detected will be reviewed by the research team, and 30-day adverse events recorded.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measure
Adenoma detection rate (ADR)
Secondary outcome measures
1. Mean adenomas detected per procedure (MAP)
2. The rate of cuff exchange (that is, how often the cuff has to be removed)
3. Caecal intubation rates and insertion time to terminal ileum (to demonstrate non-inferiority)
4. Complete withdrawal time in procedures where no polyps are detected (to demonstrate non-inferiority)
5. Patient satisfaction
6. To identify any difference in future colonoscopic workload produced by increased adenoma detection rate in terms of number of potential follow-up procedures based on BSG adenoma surveillance guidelines between the EAC and SC groups
Overall trial start date
06/10/2014
Overall trial end date
30/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18 years and over
2. Referral for screening, surveillance or diagnostic colonoscopy
3. Ability to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1772 participants (886 in each arm of the study)
Participant exclusion criteria
1. Absolute contraindications to colonoscopy
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 would be likely to prevent passage of the colonoscope)
6. Patients with acute colitis (ulcerative, Crohns and diverticulitis)
7. Patients lacking capacity to give informed consent
8. Pregnancy
Recruitment start date
06/10/2014
Recruitment end date
30/06/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
South Tyneside Hospital
South Shields
NE34 0PL
United Kingdom
Sponsor information
Organisation
South Tyneside NHS Foundation Trust (UK)
Sponsor details
South Tyneside Hospital
Harton Lane
South Shields
NE34 0PL
United Kingdom
+44 (0)191 404 1000
claire.livingstone@stft.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
ARC Medical Design Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29363535