Clinical Research Directory
Browse clinical research sites, groups, and studies.
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.
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
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