Adenoma Detection Rate Using Endocuff Vision in China

Study Overview
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Brief Summary
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The primary aim of this study is - to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Endocuff Vision is used. Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT

Detailed Description
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Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve adenoma detection rates. A new device, called the Endocuff Vision has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous 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 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 will be invited in 5 centres, recruiting a total of 1200 participants.

Official Title
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Adenoma Detection Rate Using Endocuff Vision in China

Conditions
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Colorectal Neoplasms, Colonic Polyp, Adenoma

Intervention / Treatment
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* Device: Endocuff Vision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients referred for screening, surveillance, or diagnostic colonoscopy All patients must be able to give informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endocuff Vision-assisted Colonoscopy<br>Participants in this arm undergo Endocuff Vision-assisted colonoscopy | Device: Endocuff Vision<br>* Endocuff Vision is attached to the tip of colonoscope before intubation.<br>|
| No Intervention: Standard Colonoscopy<br>Participants in this arm undergo standard colonoscopy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate, ADR | ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma. | At the end of the procedure, up to 1 hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate, PDR | PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp. | At the end of the procedure, up to 1 hour. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenoma detection rate