NCT07089615

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

Prospective, Open Label, Pivotal Study of the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Capso Vision, Inc. · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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® 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

Conditions

• Colonic Polyps

Interventions

Type	Name	Description
DEVICE	Capsule swallow	Participant will swallow the investigational device

Timeline

• Start date: 2025-06-26
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study