Clinical Trial: Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference

U.S., July 29 -- ClinicalTrials.gov registry received information related to the study (NCT07089615) titled 'Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference' on July 16.

Brief Summary: Note: This is the same study protocol as NCT04607746 with slight changes to how the videos will be read and a 2nd generation capsule is being studied.

The purpose of this study is to evaluate the safety and effectiveness of CapsoCam(R) Colon (CV-3) endoscope system for the detection of colonic polyps and to show that AI-based CADe improves the polyp-detection accuracy and efficiency of capsule video readers. It will use colonoscopy results as a reference....