Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

Study Overview
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Brief Summary
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Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)

Detailed Description
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The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.

Official Title
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Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study

Conditions
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Colorectal Polyps, Colorectal Adenomas

Intervention / Treatment
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* Device: Arc Endocuff (AEC 110, 120, 130, 140)
* Device: Cap
* Device: Standard colonoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colonoscopy independent from indication Age ≥ 18 Patient is able to provide informed consent for the procedure Exclusion Criteria: Inflammatory Bowel Disease stenosis Pregnant of nursing patient Acute diverticulitis Active Inflammatory Bowel Disease Age ≤ 18 Coagulation disorder (INR>1.4 , Thrombocytes < 50000/µl)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arc Endocuff (AEC 110, 120, 130, 140)<br>Endocuff-assisted colonoscopy Colonoscopy with the Endocuff attached at the distal tip of the scope | Device: Arc Endocuff (AEC 110, 120, 130, 140)<br> <br> |
| Active Comparator: Cap<br>Cap-assisted colonoscopy Colonoscopy with the transparent Cap attached at the distal tip of the scope | Device: Cap<br>* Olympus Disposable distal attachment 15mm diameter, 4mm depth<br>|
| Active Comparator: Standard Colonoscope<br>Standard colonoscopy without any additional device | Device: Standard colonoscope<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | Proportion of patients having at least one adenoma | 1 year | 
| Polyp detection rate | Proportion of patients having at least one adenoma | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel preparation result |  | one day | 
| Coecum intubation rate |  | one year | 
| Ileum intubation rate |  | one year | 
| Coecum intubation time |  | one day | 
| withdrawal time |  | one day | 
| mucosal laceration |  | one day | 
| severe bleeding |  | one day | 
| perforation |  | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenoma detection rate, polyp detection rate, withdrawal time, coecal and ileum intubation rate