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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.
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.
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
Age
All ages
Sex
ALL
Healthy Volunteers
Yes
Helios Dr. Horst Schmidt Kliniken
Wiesbaden, Germany
Start Date
March 1, 2022
Primary Completion Date
December 1, 2022
Completion Date
December 1, 2022
Last Updated
April 8, 2022
372
ESTIMATED participants
Standard Colonoscopy
DEVICE
CAD-EYE
DEVICE
G-EYE
DEVICE
Lead Sponsor
Dr. Horst Schmidt Klinik GmbH
NCT04569591
NCT06950385
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT03050268