NCT04651062

Detection of Adenomas in Screening Colonoscopy

Detection of Adenomas in Screening Colonoscopy - Endocuff Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,178 (actual)
• Sponsor: Herning Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The Endocuff study aims to show an increase of the number of detected adenomas in screening colonoscopies when a endocuff vision (Arc Medical Design Ldt Leeds England) is used.

Detailed description

Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope. Several minor studies have shown that the use of Endocuff probably increases the number of detected polyps in colonoscopy. Endocuff is made of soft plastic and has been designed to give an optimal view of the entire colon. It gently averts and flattens folds in order to see small polyps "hiding" in the space behind colonic folds. The purpose of this study is to investigate into the effect of the Endocuff in screening colonoscopy compared with screening colonoscopy performed without Endocuff. The device has been used during several years yet an effect on the number of polyps detected during screenings colonoscopy has not been shown. This studies main hypothesis is that the use of Endocuff in screenings colonoscopy will increase the adenoma detection rate in these patients, with a potential to reduce interval cancer. This study is a randomized controlled trial with 900 patients.

Conditions

• Adenoma Colon

Interventions

Type	Name	Description
DEVICE	endocuff	Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.
PROCEDURE	no endocuff	colonoscopy is performed without endocuff.

Timeline

• Start date: 2017-10-01
• Primary completion: 2018-12-01
• Completion: 2020-04-01
• First posted: 2020-12-03
• Last updated: 2020-12-03

Locations

1 site across 1 country: Denmark