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

Prospective, Open Label, Pivotal Study of the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

Not applicable Interventional Capso Vision, Inc. · NCT07089615

This study will test whether a second-generation swallowable capsule camera with AI helps detect colon polyps in adults aged 45–75 who are already scheduled for a colonoscopy.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment330 (estimated)
Ages45 Years to 75 Years
SexAll
SponsorCapso Vision, Inc. Industry-sponsored
Drugs / interventionsradiation
Locations11 sites (Chula Vista, California and 10 other locations)
Trial IDNCT07089615 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 45–75 who are willing to swallow the capsule, agree to a follow-up colonoscopy, and consent to release their colonoscopy images and reports to the sponsor.

Not a fit: People with recent clear colonoscopy or CT-colonography within five years, those with high-risk genetic syndromes, inflammatory bowel disease, bowel obstruction risks, or any contraindication to capsule endoscopy or colonoscopy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the capsule plus AI could help find more polyps noninvasively and reduce lesions missed by visual review alone.

How similar studies have performed: Earlier capsule-colonoscopy and AI-assisted polyp-detection studies have shown promise, but combining a second-generation capsule with an AI CADe for routine polyp detection is relatively new.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chula Vista, California and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colonic Polyps
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.