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Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference | Clinical Trials | Clareo Health

RECRUITINGNA

Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference

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

NCT07089615•Capso Vision, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

45 - 75 years

Sex

ALL

Healthy Volunteers

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
+14 more criteria

Locations (11)

SB Gastro Clinical Research

Chula Vista, California, United States

Gastro Care Institute

Lancaster, California, United States

Knowledge Research Center

Orange, California, United States

Advanced Research Institute

St. Petersburg, Florida, United States

Digestive Health Services

Downers Grove, Illinois, United States

Gastroenterology and Internal Medicine Specialists

Lake Barrington, Illinois, United States

Northshore Center for Gastroenterology

Libertyville, Illinois, United States

Suburban Gastroenterology

Naperville, Illinois, United States

Southwest Gastroenterology

Oak Lawn, Illinois, United States

Gastroenterology Group of Rochester

Rochester, New York, United States

Key Dates

Start Date

June 26, 2025

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2026

Last Updated

July 28, 2025

Enrollment

330

ESTIMATED participants

Conditions

Colonic Polyps

Interventions

Capsule swallow

DEVICE

Contacts

Taylor Williamsen Principle CRA/Study Lead

CONTACT

815-861-9575 taylor.williamsen@capsovision.com

Rebecca Petersen Sr. Director of Clinical Affairs

CONTACT

510-566-8824 rebecca.petersen@capsovision.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference

Inclusion Criteria

Exclusion Criteria

Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

Comparison Rectal Endoscopic Submucosal Dissection to Endoscopic Mucosal Resection

Retrospective Review of Gastrointestinal System Endoscopy Procedures

Cold Polypectomy Site Study

Endoscopic Assessment of Polyp Histology

Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion