Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

561 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-02-01

Brief Summary

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

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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.

Conditions

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Colorectal Polyps Colorectal Adenomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Arc Endocuff (AEC 110, 120, 130, 140)

Endocuff-assisted colonoscopy Colonoscopy with the Endocuff attached at the distal tip of the scope

Group Type ACTIVE_COMPARATOR

Arc Endocuff (AEC 110, 120, 130, 140)

Intervention Type DEVICE

Cap

Cap-assisted colonoscopy Colonoscopy with the transparent Cap attached at the distal tip of the scope

Group Type ACTIVE_COMPARATOR

Cap

Intervention Type DEVICE

Olympus Disposable distal attachment 15mm diameter, 4mm depth

Standard Colonoscope

Standard colonoscopy without any additional device

Group Type ACTIVE_COMPARATOR

Standard colonoscope

Intervention Type DEVICE

Interventions

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Arc Endocuff (AEC 110, 120, 130, 140)

Intervention Type DEVICE

Cap

Olympus Disposable distal attachment 15mm diameter, 4mm depth

Intervention Type DEVICE

Standard colonoscope

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No