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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05318495
Study type Interventional
Source Dr. Horst Schmidt Klinik GmbH
Contact Ralf Kiesslich, Prof.
Phone 49-611432421
Email Ralf.Kiesslich@helios-gesundheit.de
Status Recruiting
Phase N/A
Start date March 1, 2022
Completion date December 2022

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