NCT02331836

Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 561 (actual)
• Sponsor: Helios Albert-Schweitzer-Klinik Northeim · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Colorectal Polyps
• Colorectal Adenomas

Interventions

Type	Name	Description
DEVICE	Arc Endocuff (AEC 110, 120, 130, 140)
DEVICE	Cap	Olympus Disposable distal attachment 15mm diameter, 4mm depth
DEVICE	Standard colonoscope

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2015-01-06
• Last updated: 2019-02-12

Locations

6 sites across 2 countries: Germany, Poland