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
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
Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
Has contraindication for capsule endoscopy or colonoscopy
Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
Capso Vision, Inc.
Lead sponsor