NCT05158725

Comparison of Colonoscopy Adenoma Detection Yield

Comparison of Colonoscopy Adenoma Detection Yield of Standard Colonoscopy, Discovery Aided Colonoscopy, and Discovery and G-EYE® Aided Colonoscopy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,320 (estimated)
• Sponsor: Dr. Horst Schmidt Klinik GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy.

Detailed description

Multi-center, three-arm, randomized, controlled, open-label study. Total of up to 1320 patients will be randomized, including up to 10% for subject drop-out, 440 to each of the three following arms (groups): Group 1 (1st arm): patients will receive standard colonoscopy (SC) Group 2 (2nd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software (DC) Group 3 (3rd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software and the G-EYE® balloon (GDC) The purpose of this study is to compare between the diagnostic yield of Standard Colonoscopy, Discovery aided colonoscopy, and Discovery \& G-EYE® aided colonoscopy.

Conditions

• Adenoma Colon

Interventions

Type	Name	Description
DEVICE	Standard Colonoscopy	In this arm, subjects will undergo colonoscopy using a standard colonoscope
DEVICE	Discovery aided colonoscopy	the Discovery is a customized detection support software, developed utilizing AI deep learning technology to support endoscopic lesion detection in the colon. In this arm, a standard colonoscope is used with the Discovery.
DEVICE	Discovery and G-EYE	The G-EYE® Endoscope is a standard colonoscope which is remanufactured by installing the G-EYE® balloon on the distal bending section of the colonoscope. in this arm, the G-EYE® Endoscope is used with the Discovery

Timeline

• Start date: 2021-11-08
• Primary completion: 2022-05-01
• Completion: 2022-06-01
• First posted: 2021-12-15
• Last updated: 2021-12-15

Locations

1 site across 1 country: Germany