Data Collection for CV-3E AI Software Development

Last updated: April 1, 2025
Sponsor: Capso Vision, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polyps

Colon Polyps

Treatment

Colon Capsule

Clinical Study ID

NCT06916845
CLN-CVI-7472
  • Ages 45-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to collect capsule images for the development of CADe software for use with the CapsoCam® Colon (CV-3E) in healthy volunteers who have been referred for colonoscopy. There will be no analysis performed as part of this protocol.

Participants will

  • adhere to bowel prep instructions and dietary requirements

  • ingest pro-kinetic medication and CapsoCam® Colon (CV-3E)

  • adhere to booster regimen and dietary requirements until capsule passes

  • retrieve capsule with retrieval kit per instructions and mail back to sponsor

  • participate in follow-up phone call

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 45-75 years of age

  2. Choose to participate and must have signed the IRB-approved informed consentdocument.

Exclusion

Exclusion Criteria:

  1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps

  2. Colonoscopy within the past 4 years that demonstrated polyps that were removed.

  3. Has contraindication for capsule endoscopy

  4. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditarynon polyposis colon cancer, or any high-risk genetic syndrome

  5. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerativecolitis or Crohn's disease

  6. History of incomplete colonoscopy

  7. Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C>6.4 within thepast 3 months and/or with history of constipation or gastroparesis).

  8. Impaired cardiac function assessed as greater than NYHA Class II

  9. History of small- or large-bowel obstructive condition

  10. Known history of swallowing disorder, and/or ischemic bowel disease neuropathiesand/or radiation enteritis

  11. Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on aregular basis that, in the opinion of the Investigator, would put the subject atgreater risk for capsule endoscope retention

  12. Known allergy to ingredients used in bowel preparation and boosters

  13. Daily and/or regular narcotic use

  14. Decompensated cirrhosis

  15. Prior abdominal radiation therapy

  16. Diagnosis of anorexia or bulimia

  17. History of or suspicion of any of the following: strictures, volvulus or intestinalobstruction, or internal hernias or abdominal surgeries that the Investigatorbelieves should exclude the patient from study participation

  18. Known or suspected megacolon

  19. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule

  20. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis

  21. Pregnant or nursing or of child-bearing potential and does not agree to practicemedically acceptable methods of contraception. Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at screening.

  22. Unable to follow or tolerate fasting, bowel preparation, and other study procedures

  23. Any documented medical or psychological condition or significant concurrent illnesswhich, in the Investigator's opinion, would make it unsafe for the subject toparticipate in this research study or would affect the validity of the study results

  24. Are currently enrolled in an interventional clinical study or currently enrolled inor within the last 30 days, a pharmaceutical clinical study

  25. Chronic constipation as defined by <3 bowel movements per week, or the use ofroutine laxatives (other than fiber) to attain regular bowel movements

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Colon Capsule
Phase:
Study Start date:
March 18, 2025
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Advanced Research Institute Inc

    New Port Richey, Florida 34653
    United States

    Active - Recruiting

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida 34684
    United States

    Active - Recruiting

  • Digestive Diseases Center of Hattiesburg, LLC

    Hattiesburg, Mississippi 39402
    United States

    Active - Recruiting

  • Gastroenterology Consultants of Southwest Virginia

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

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