Skip to main content
Colonic PolypsDiagnostics and screeningDevice

What this study is

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

What's being tested

  • Capsule swallow

    Intervention · DEVICE

    Participant will swallow the investigational device

Study details

Official title
Prospective, Open Label, Pivotal Study of the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
Sponsor
Capso Vision, Inc.
Conditions
Colonic Polyps
Enrolling
330 people
Starts
2025-06-26
Est. completion
2026-12
Design
Open-label, single group
Record
View on ClinicalTrials.gov ↗