Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
ADENOMA
3 other identifiers
interventional
1,772
1 country
7
Brief Summary
The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
7 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
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedSeptember 16, 2015
September 1, 2015
1.6 years
September 10, 2015
September 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma detection rate
A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.
10 months
Secondary Outcomes (10)
Mean adenomas detected per procedure
10 months
Rate of cuff exchange
10 months
Effect on duration of caecal intubation rates
10 months
Patient satisfaction using validated patient comfort Bowel Cancer Screening Programme (BCSP) questionnaires
10 months
Increase in surveillance colonoscopies caused by increased adenoma detection rate
10 months
- +5 more secondary outcomes
Study Arms (2)
Endocuff Vision-assisted Colonoscopy
ACTIVE COMPARATORParticipants in this arm undergo Endocuff Vision-assisted colonoscopy
Standard Colonoscopy
NO INTERVENTIONParticipants in this arm undergo standard colonoscopy
Interventions
Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).
Eligibility Criteria
You may qualify if:
- All patients referred for screening, surveillance, or diagnostic colonoscopy
- All patients must be able to give informed consent
You may not qualify if:
- Patients with any absolute contraindications to colonoscopy
- Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
- Patients with known colon cancer or polyposis syndromes
- Patients with known colonic strictures
- Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
- Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
- Patients lacking capacity to give informed consent
- Pregnancy
- Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
- Patients who are attending for a therapeutic procedure or assessment of a known lesion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
County Durham and Darlington NHS Foundation Trust
Durham, County Durham, DL3 6HX, United Kingdom
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, County Durham, TS19 8PE, United Kingdom
St Mark's Hospital and Academic Institute
Harrow, Middlesex, HA1 3UJ, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Shields, Tyne and Wear, NE29 8NH, United Kingdom
South Tyneside NHS Foundation Trust
South Shields, Tyne and Wear, NE34 0PL, United Kingdom
City Hospitals Sunderland NHS Foundation Trust
Sunderland, Tyne and Wear, SR4 7TP, United Kingdom
Related Publications (1)
Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23.
PMID: 29363535DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Colin Rees, MBBS, FRCP
South Tyneside and Sunderland NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2015
First Posted
September 16, 2015
Study Start
November 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
September 16, 2015
Record last verified: 2015-09