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
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: f
View:
• 45-75 years of age
• Committed to undergo a colonoscopy.
• Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor
Locations
United States
California
SB Gastro Clinical Research
RECRUITING
Chula Vista
Gastro Care Institute
RECRUITING
Lancaster
Knowledge Research Center
RECRUITING
Orange
Florida
Advanced Research Institute
RECRUITING
St. Petersburg
Illinois
Digestive Health Services
RECRUITING
Downers Grove
Gastroenterology and Internal Medicine Specialists
RECRUITING
Lake Barrington
Northshore Center for Gastroenterology
RECRUITING
Libertyville
Suburban Gastroenterology
RECRUITING
Naperville
Southwest Gastroenterology
RECRUITING
Oak Lawn
New York
Gastroenterology Group of Rochester
RECRUITING
Rochester
Ohio
Great Lakes Gastroenterology Research
RECRUITING
Mentor
Contact Information
Primary
Taylor Williamsen Principle CRA/Study Lead
taylor.williamsen@capsovision.com
815-861-9575
Backup
Rebecca Petersen Sr. Director of Clinical Affairs
rebecca.petersen@capsovision.com
510-566-8824
Time Frame
Start Date:2025-06-26
Estimated Completion Date:2026-01
Participants
Target number of participants:330
Treatments
Experimental: A new capsule design is being used from that of the first phase of the study.