Status: Recruiting
Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference
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® 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. The participant will: 1. prep for and swallow a study capsule and then 2. prep for and undergo a colonoscopy either the following day or 3-6 weeks later
Participants needed: 330
Trial details
Age: 45-75Biological sex: AllType: InterventionalSponsor: Capso Vision, Inc.Updated: May 8, 2026Locations: 11
Eligibility criteria
45-75 years of age [+2]
Colonoscopy or CT-colonography within the past 5 years that demonstrated no poly... [+23]