Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities (ADENOMA)
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|ClinicalTrials.gov Identifier: NCT02552017|
Recruitment Status : Unknown
Verified September 2015 by South Tyneside and Sunderland NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : September 16, 2015
Last Update Posted : September 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms Colonic Polyps Adenoma||Device: Endocuff Vision||Not Applicable|
Bowel cancer is common in the United Kingdom, with around 1 in 16 men and 1 in 20 women developing it at some point in their lives. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous. Doctors use a camera test, known as a colonoscopy, to look inside the bowel and find these polyps and remove them. Removing precancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. How good colonoscopists are at finding these polyps varies, and there is a lot of research into how to improve "adenoma detection rates".
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1772 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Active Comparator: Endocuff Vision-assisted Colonoscopy
Participants in this arm undergo Endocuff Vision-assisted colonoscopy
Device: 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).
No Intervention: Standard Colonoscopy
Participants in this arm undergo standard colonoscopy
- Adenoma detection rate [ Time Frame: 10 months ]A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.
- Mean adenomas detected per procedure [ Time Frame: 10 months ]A difference in mean adenomas detected per procedure between both groups
- Rate of cuff exchange [ Time Frame: 10 months ]The rate of cuff exchange (that is, how often the cuff has to be removed) between both groups
- Effect on duration of caecal intubation rates [ Time Frame: 10 months ]Duration of complete withdrawal time in procedures where no polyps are detected between both groups
- Patient satisfaction using validated patient comfort Bowel Cancer Screening Programme (BCSP) questionnaires [ Time Frame: 10 months ]Patient satisfaction measured from no pain (0) to severe pain (3), episodes of discomfort from no discomfort (0) to frequent (more than 4 times)(3), length of discomfort from no discomfort (0) to more than 1 minute(3).
- Increase in surveillance colonoscopies caused by increased adenoma detection rate [ Time Frame: 10 months ]Increase in surveillance colonoscopies due to increased adenoma detection rate in terms of number of potential follow up procedures based on British Society of Gastroenterology adenoma surveillance guidelines in both groups
- Number of proximal sessile serrated polyps by histology [ Time Frame: 10 months ]Number of of proximal sessile serrated polyps in both groups
- Polyp location [ Time Frame: 10 months ]Distribution of polyps in the colon in both groups by location
- Adenoma detection rate of BCSP and non-BCSP endoscopists [ Time Frame: 10 months ]Adenoma detection rate of BCSP and non-BCSP colonoscopists
- Change in adenoma detection rate of each endoscopist during the course of the trial [ Time Frame: 10 months ]Adenoma detection rate (ADR) of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR.
- Adenoma detection rate of individual endoscopist before and after trial commencement [ Time Frame: 10 months ]Baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where Endocuff Vision was not used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552017
|Contact: Wee Sing Ngu, MBChB, MRCS||01914041000 ext email@example.com|
|Contact: Gayle Clifford, BSc||01914041000 ext firstname.lastname@example.org|
|County Durham and Darlington NHS Foundation Trust||Recruiting|
|Durham, County Durham, United Kingdom, DL3 6HX|
|Contact: John Silcock, MBBS, FRCP 01325 380100 John.Silcock@cddft.nhs.uk|
|Principal Investigator: John Silcock, MBBS, FRCP|
|North Tees and Hartlepool NHS Foundation Trust||Recruiting|
|Stockton-on-Tees, County Durham, United Kingdom, TS19 8PE|
|Contact: Matthew Rutter, MBBS, FRCP 01642 617617 Matt.email@example.com|
|Principal Investigator: Matthew Rutter, MBBS, FRCP|
|St Mark's Hospital and Academic Institute||Recruiting|
|Harrow, Middlesex, United Kingdom, HA1 3UJ|
|Contact: Brian Saunders, MBBS, FRCP 02082354000 firstname.lastname@example.org|
|Principal Investigator: Brian Saunders, MBBS, FRCP|
|South Tees Hospitals NHS Foundation Trust||Recruiting|
|Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW|
|Contact: Arvind Ramadas, MBBS, FRCP 01642 854860 Arvind.Ramadas@stees.nhs.uk|
|Principal Investigator: Arvind Ramadas, MBBS,FRCP|
|Northumbria Healthcare NHS Foundation Trust||Recruiting|
|North Shields, Tyne and Wear, United Kingdom, NE29 8NH|
|Contact: Thomas Lee, MBBS, FRCP 0344 811 8111 Tom.Lee@northumbria-healthcare.nhs.uk|
|Principal Investigator: Thomas Lee, MBBS, FRCP|
|South Tyneside NHS Foundation Trust||Recruiting|
|South Shields, Tyne and Wear, United Kingdom, NE34 0PL|
|Contact: Wee Sing Ngu, MBChB, MRCS 01914041000 ext 2899 email@example.com|
|Contact: Gayle Clifford, BSc 01914041000 ext 4756 firstname.lastname@example.org|
|Principal Investigator: Colin Rees, MBBS, FRCP|
|City Hospitals Sunderland NHS Foundation Trust||Recruiting|
|Sunderland, Tyne and Wear, United Kingdom, SR4 7TP|
|Contact: John Painter, MBBS, FRCP 0191 565 6256 John.Painter@chsft.nhs.uk|
|Principal Investigator: John Painter, MBBS, FRCP|
|Principal Investigator:||Colin Rees, MBBS, FRCP||South Tyneside and Sunderland NHS Foundation Trust|