Comparing a new swallowable colon capsule with AI to standard colonoscopy for finding colon polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants will swallow the CapsoCam® Colon (CV-3) capsule, which records 360-degree images of the colon, and then undergo a standard colonoscopy the following day or within 3–6 weeks. Capsule videos will be read with and without an AI-based CADe tool to see if the AI improves readers' speed and polyp-detection accuracy. Colonoscopy findings serve as the reference standard to compare which polyps the capsule and AI detect or miss. The study is open-label, non-significant risk, and conducted at multiple clinical sites in California using a second-generation capsule and a revised video-reading protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 45-75 years of age
2. Committed to undergo a colonoscopy.
3. 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:

1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
2. Has contraindication for capsule endoscopy or colonoscopy
3. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
4. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
5. History of incomplete colonoscopy
6. 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).
7. Impaired cardiac function assessed as greater than NYHA Class II
8. History of small- or large-bowel obstructive condition
9. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
10. Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the subject at greater risk for capsule endoscope retention
11. Known allergy to ingredients used in bowel preparation and boosters
12. Daily and/or regular narcotic use
13. Decompensated cirrhosis
14. Prior abdominal radiation therapy
15. Diagnosis of anorexia or bulimia
16. History of or suspicion of any of the following: strictures, volvulus or intestinal obstruction, or internal hernias or abdominal surgeries that the Investigator believes should exclude the patient from study participation
17. Known or suspected megacolon
18. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
19. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
20. Pregnant or nursing or of child-bearing potential and does not agree to practice medically acceptable methods of contraception. Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at screening.
21. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
22. Any documented medical or psychological condition or significant concurrent illness which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study or would affect the validity of the study results
23. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
24. Chronic constipation as defined by \<3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements

Where it's running

• SB Gastro Clinical Research
  Chula Vista, California, United States Recruiting
• Gastro Care Institute
  Lancaster, California, United States Recruiting
• Knowledge Research Center
  Orange, California, United States Recruiting
• Advanced Research Institute
  St. Petersburg, Florida, United States Recruiting
• Digestive Health Services
  Downers Grove, Illinois, United States Recruiting
• Gastroenterology and Internal Medicine Specialists
  Lake Barrington, Illinois, United States Recruiting

Study contacts

• Principal investigator: Suejin Kim Study PI, M.D.
• Study coordinator: Taylor Williamsen Principle CRA/Study Lead
• Email: taylor.williamsen@capsovision.com
• Phone: 815-861-9575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.