Study to Test the Accuracy of the CapsoCam4 Colon Capsule in Finding Colon Polyps Compared to Colonoscopy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the CapsoCam4 Colon CV-3 endoscope system in detecting colonic polyps. This study aims to determine whether the AI-based computer-aided detection CADe feature improves the accuracy and efficiency of reading capsule videos. Colonoscopy results will be used as the reference standard to compare findings from the capsule system. Participants will prepare for and swallow the study capsule, which includes a new second-generation design. After the capsule procedure, participants will undergo a colonoscopy either the following day or between 3 to 6 weeks later. This allows researchers to compare the capsule findings with the colonoscopy results. During the study, participants will be monitored from the time of the capsule swallow up to the colonoscopy within 6 weeks. The main outcomes measured include the positive and negative percentage agreement between the capsule system and the colonoscopy in detecting polyps. Participants will complete required preparation and procedures, and safety and effectiveness data will be collected throughout the study period.

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