Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy (EC-Cap-SC)

Helios Albert-Schweitzer-Klinik Northeim

Status: Completed

Conditions: Colorectal Polyps; Colorectal Adenomas

Treatments: Device: Standard colonoscope; Device: Cap; Device: Arc Endocuff (AEC 110, 120, 130, 140)

Study type: Interventional

Funder types: Other

Identifiers

NCT02331836

EC-CUFF-2015

Details and patient eligibility

About

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

Full description

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.

Enrollment: 561 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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561 participants in 3 patient groups

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

Active Comparator group

Description:

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

Treatment:

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

Cap

Active Comparator group

Description:

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

Treatment:

Device: Cap

Standard Colonoscope

Active Comparator group

Description:

Standard colonoscopy without any additional device

Treatment:

Device: Standard colonoscope