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
Single group
Capsule swallow
DeviceParticipant will swallow the investigational device
Positive Percentage Agreement
• Positive Percent Agreement (PPA) of the study device with computer assisted detection (CADe) for detecting the presence in a subject of the largest polyp detected by optical colonoscopy (OC) if that polyp is ≥ 6 mm, where a match is considered to have occurred if a polyp detected by the device is assessed as having a size within plus or minus 50% of the size of the polyp detected by OC and as having a location within the same or an adjacent colon segment.
Negative Percentage Agreement
• Negative percent agreement (NPA) of the study device with CADe for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm.
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