BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
B-ADENOMA
1 other identifier
interventional
3,221
1 country
16
Brief Summary
This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2017
CompletedStudy Start
First participant enrolled
February 14, 2017
CompletedFirst Posted
Study publicly available on registry
March 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2018
CompletedSeptember 6, 2018
September 1, 2018
12 months
January 16, 2017
September 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma Detection Rate
Proportion of examinations expressed as a percentage where at least one adenoma is found
Day of procedure
Secondary Outcomes (12)
Mean adenomas detected per procedure
Day of procedure
Rate of cuff exchange
Day of procedure
Non-inferiority of complete withdrawal time in procedures where no polyps are detected
Day of procedure
Compare overall procedure time between groups
Day of procedure
Measure differences in ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation).
Day of procedure
- +7 more secondary outcomes
Study Arms (2)
Endocuff-assisted Flexible Sigmoidoscopy
EXPERIMENTALPatients in this arm will receive their screening sigmoidoscopy with the Endocuff Vision in situ on the scope
Standard Flexible Sigmoidoscopy
NO INTERVENTIONPatients in this arm will receive their screening sigmoidoscopy without the Endocuff on the scope
Interventions
The EndocuffTM (ARC Medical Design Ltd and Diagmed, UK) is a device (CE marked in UK) made of a soft plastic material with a unique dynamic shape. Endocuff Vision™ is placed snugly around the colonoscope tip prior to insertion. It does not project beyond the tip of the scope, providing an unrestricted view. It helps anchor the scope tip against the bowel wall to provide a stable platform of access. The soft, elastic projections are pushed back (recoiled) towards the scope shaft during insertion but evert during withdrawal to hold colon folds away from the field of view.
Eligibility Criteria
You may qualify if:
- Age 18 years and over
- Referral for screening flexible sigmoidoscopy
- Ability to give informed consent
You may not qualify if:
- Absolute contraindications to flexible sigmoidoscopy
- Established or suspicion of large bowel obstruction or pseudo-obstruction
- Known colon cancer or polyposis syndromes
- Known colonic strictures
- Known severe diverticular segment (that is likely to impede sigmoidoscope passage)
- Patients with known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
- Patients lacking capacity to give informed consent
- Patients who are on clopidogrel, warfarin, or other new generation anticoagulants which have not been stopped for the procedure as these will preclude polyp removal
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- South Tyneside and Sunderland NHS Foundation Trustlead
- ARC Medical Design Ltdcollaborator
- Norginecollaborator
Study Sites (16)
South Tyneside NHS Foundation Trust
South Shields, Tyne and Wear, NE34 0PL, United Kingdom
Bolton NHS Foundation Trust
Bolton, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Cheltenham, GL53 7AN, United Kingdom
Dorset Healthcare University NHS Trust
Dorchester, United Kingdom
County Durham and Darlington NHS Foundation Trust
Durham, DH1 5TW, United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal, LA9 7RG, United Kingdom
Kettering General Hospital NHS Trust
Kettering, NN16 8UZ, United Kingdom
North West London Hospitals NHS Trust
London, HA1 3UJ, United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Shields, NE29 8NH, United Kingdom
Oxford Health NHS Trust
Oxford, OX3 9DU, United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, PO6 3LY, United Kingdom
Pennine Acute Hospitals NHS Trust
Rochdale, OL12 0NB, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S5 7AU, United Kingdom
North Tees and Hartlepool NHS Trust
Stockton-on-Tees, TS19 8PE, United Kingdom
West Hertfordshire Hospitals NHS Trust
Watford, United Kingdom
The Royal Wolverhamptom NHS Trust
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
Rees CJ, Brand A, Ngu WS, Stokes C, Hoare Z, Totton N, Bhandari P, Sharp L, Bastable A, Rutter MD, Verma AM, Lee TJ, Walls M; B-ADENOMA trial group comprises. BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial. Gut. 2020 Nov;69(11):1959-1965. doi: 10.1136/gutjnl-2019-319621. Epub 2020 Apr 3.
PMID: 32245908DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Colin J Rees, MBBS MRCP FRCP
South Tyneside and Sunderland NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2017
First Posted
March 7, 2017
Study Start
February 14, 2017
Primary Completion
February 13, 2018
Study Completion
February 13, 2018
Last Updated
September 6, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share