NCT04708951

Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE®

A Prospective Randomized Comparison of Colonoscopy Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®) (Endocuff) Versus a Permanently Mounted Balloon (G-EYE®)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 970 (actual)
• Sponsor: Dr. Horst Schmidt Klinik GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The study is intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.

Detailed description

This is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.

Conditions

• Adenoma
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	ENDOCUFF VISION® device	ENDOCUFF VISION® is a disposable cap placed on the tip of a standard colonoscope, intended to flatten colonic folds and assist in controlling the colonoscope's field of view and tip positioning
DEVICE	G-EYE® colonoscope	The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-10-01
• Completion: 2021-10-15
• First posted: 2021-01-14
• Last updated: 2021-10-22

Locations

3 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study