Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
NCT ID: NCT02552017
Last Updated: 2015-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
1772 participants
INTERVENTIONAL
2014-11-30
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
NCT03072472
Detection of Adenomas in Screening Colonoscopy
NCT04651062
Endocuff Adenoma Detection Rate Pilot Study
NCT01761097
Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.
NCT02374515
Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening
NCT02529007
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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) has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy (via the symptomatic service, surveillance procedures, and the Bowel Cancer Screening Programme) will be invited in 7 centres (a mixture of specialist centres and district general hospitals), recruiting a total of 1772 participants.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Endocuff Vision-assisted Colonoscopy
Participants in this arm undergo Endocuff Vision-assisted colonoscopy
Endocuff Vision
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).
Standard Colonoscopy
Participants in this arm undergo standard colonoscopy
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Endocuff Vision
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. All patients must be able to give informed consent
Exclusion Criteria
2. Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
3. Patients with known colon cancer or polyposis syndromes
4. Patients with known colonic strictures
5. Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
7. Patients lacking capacity to give informed consent
8. Pregnancy
9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
10. Patients who are attending for a therapeutic procedure or assessment of a known lesion
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
South Tyneside and Sunderland NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Colin Rees, MBBS, FRCP
Role: PRINCIPAL_INVESTIGATOR
South Tyneside and Sunderland NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
County Durham and Darlington NHS Foundation Trust
Durham, County Durham, United Kingdom
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, County Durham, United Kingdom
St Mark's Hospital and Academic Institute
Harrow, Middlesex, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, North Yorkshire, United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Shields, Tyne and Wear, United Kingdom
South Tyneside NHS Foundation Trust
South Shields, Tyne and Wear, United Kingdom
City Hospitals Sunderland NHS Foundation Trust
Sunderland, Tyne and Wear, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17718
Identifier Type: REGISTRY
Identifier Source: secondary_id
1182104
Identifier Type: REGISTRY
Identifier Source: secondary_id
039/2014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.