Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of… (NCT07089615) | Clinical Trial Compass
RecruitingNot Applicable
Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference
United States330 participantsStarted 2025-06-26
Plain-language 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
Who can participate
Age range45 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. History of incomplete colonoscopy
✕. Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C\>6.4 within the past 3 months and/or with history of constipation or gastroparesis).
What they're measuring
1
Positive Percentage Agreement
Timeframe: From capsule swallow to Colonoscopy - up to 6 weeks
2
Negative Percentage Agreement
Timeframe: From Capsule swallow to colonoscopy - Up to 6 weeks