NCT05318495

A Dual Tandem Study - SC vs. CAD-EYE vs. CAD-EYE With G-EYE

A Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of SC to That of Artificial Intelligence (CAD-EYE) Aided Colonoscopy and to That of Artificial Intelligence (CAD-EYE) and G-EYE® Aided Colonoscopy.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 372 (estimated)
• Sponsor: Dr. Horst Schmidt Klinik GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices: 1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas. 3. 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.

Detailed description

Single-center, four-arm dual-tandem, randomized, open-label study involving the following devices: 1. The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI). 2. CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas. 3. 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. Total of up to 372 patients will be randomized,186 to each of the two tandems

Conditions

• Adenoma
• Colo-rectal Cancer

Interventions

Type	Name	Description
DEVICE	Standard Colonoscopy	The Standard Colonoscope is a high-definition colonoscope employing advanced optical filtering and enhancement techniques - blue light imaging (BLI) and linked color imaging (LCI).
DEVICE	CAD-EYE	CAD-EYE is an artificial intelligence software, used in real-time during the colonoscopy procedure for aiding the identification and characterization of polyps and adenomas.
DEVICE	G-EYE	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: 2022-03-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2022-04-08
• Last updated: 2022-04-08

Locations

1 site across 1 country: Germany