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RECRUITING
NCT07089615
NA

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

Sponsor: Capso Vision, Inc.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2025-06-26

Completion Date

2026-01

Last Updated

2025-07-28

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Capsule swallow

Participant will swallow the investigational device

Locations (11)

SB Gastro Clinical Research

Chula Vista, California, United States

Gastro Care Institute

Lancaster, California, United States

Knowledge Research Center

Orange, California, United States

Advanced Research Institute

St. Petersburg, Florida, United States

Digestive Health Services

Downers Grove, Illinois, United States

Gastroenterology and Internal Medicine Specialists

Lake Barrington, Illinois, United States

Northshore Center for Gastroenterology

Libertyville, Illinois, United States

Suburban Gastroenterology

Naperville, Illinois, United States

Southwest Gastroenterology

Oak Lawn, Illinois, United States

Gastroenterology Group of Rochester

Rochester, New York, United States

Great Lakes Gastroenterology Research

Mentor, Ohio, United States