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

Last updated: August 14, 2024
Sponsor: Capso Vision, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polyps

Colon Polyps

Treatment

Capsule Endoscope

Clinical Study ID

NCT04607746
CLN-CVI-5794
  • Ages 45-75
  • All Genders

Study Summary

This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 45-75 years of age

  2. Committed to undergo a colonoscopy, independent of this study

  3. Choose to participate and must have signed the IRB-approved informed consentdocument and agreed to release colonoscopy images and results report to Sponsor

Exclusion

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, hereditarynon polyposis colon cancer, or any high-risk genetic syndrome

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

  5. History of incomplete colonoscopy

  6. Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C>6.4 within thepast 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 neuropathiesand/or radiation enteritis

  10. 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

  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 intestinalobstruction, or internal hernias or abdominal surgeries that the Investigatorbelieves 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 is of child-bearing potential and does not practice medicallyacceptable methods of contraception. WOCBP must have a negative urine pregnancy testat screening.

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

  22. 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

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

  24. 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: 1200
Treatment Group(s): 1
Primary Treatment: Capsule Endoscope
Phase:
Study Start date:
January 06, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Mayo Clinic

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Gastro Care Institute

    Lancaster, California 93534
    United States

    Active - Recruiting

  • InSite Digestive Health Care

    San Jose, California 95116
    United States

    Site Not Available

  • Kaiser Permanente Northern California

    San Leandro, California 94577
    United States

    Active - Recruiting

  • Advanced Research Institute

    New Port Richey, Florida 34653
    United States

    Active - Recruiting

  • Digestive Health Services

    Downers Grove, Illinois 60515
    United States

    Active - Recruiting

  • Northshore Center for Gastroenterology

    Libertyville, Illinois 60048
    United States

    Active - Recruiting

  • Suburban Gastroenterology

    Naperville, Illinois 60540
    United States

    Active - Recruiting

  • Southwest Gastroenterology

    New Lenox, Illinois 60451
    United States

    Active - Recruiting

  • Digestive Health Specialists

    Chelmsford, Massachusetts 01824
    United States

    Site Not Available

  • West Michigan Clinical Research Center

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Hattiesburg GI Associates

    Hattiesburg, Mississippi 39402
    United States

    Active - Recruiting

  • NY Total Medical Care

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Gastroenterology Group of Rochester

    Rochester, New York 14618
    United States

    Active - Recruiting

  • Great Lakes Gastroenterology Research

    Mentor, Ohio 44060
    United States

    Active - Recruiting

  • Tri-Cities Gastroenterology

    Kingsport, Tennessee 37633
    United States

    Active - Recruiting

  • Vilo Research

    Houston, Texas 77017
    United States

    Site Not Available

  • Gastroenterology Consultants of SW Virginia

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

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