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

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

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

Study Overview

• Status: Completed
• Conditions: Colonic Polyp
• Intervention / Treatment: Device: Capsule Endoscope

Detailed Description

The first phase of the study investigated the first generation of the capsule. The second generation capsule will be investigated in the final phase of enrollment.

• Study Type: Interventional
• Enrollment (Actual): 1337
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic
  • California
    • Lancaster, California, United States, 93534
      • Gastro Care Institute
    • Los Gatos, California, United States, 95032
      • InSite Digestive Health Care
    • Orange, California, United States, 92868
      • Knowledge Research Center
    • San Leandro, California, United States, 94577
      • Kaiser Permanente Northern California
  • Florida
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute
    • Orlando, Florida, United States, 32825
      • Digestive and Liver Center of Florida
    • Palm Harbor, Florida, United States, 34684
      • Advanced Gastroenterology Associates, LLC
    • Saint Petersburg, Florida, United States, 33710
      • Advanced Research Institute
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • Digestive Health Services
    • Libertyville, Illinois, United States, 60048
      • Northshore Center for Gastroenterology
    • Naperville, Illinois, United States, 60540
      • Suburban Gastroenterology
    • New Lenox, Illinois, United States, 60451
      • Southwest Gastroenterology
  • Massachusetts
    • Chelmsford, Massachusetts, United States, 01824
      • Digestive Health Specialists
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • West Michigan Clinical Research Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39402
      • Hattiesburg GI Associates
  • New York
    • Brooklyn, New York, United States, 11215
      • NY total Medical Care, PC
    • Rochester, New York, United States, 14618
      • Gastroenterology Group of Rochester
  • Ohio
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology Research
  • Tennessee
    • Kingsport, Tennessee, United States, 37663
      • Tri-Cities Gastroenterology
  • Texas
    • Houston, Texas, United States, 77017
      • Vilo Research Group
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Gastroenterology Consultants of SW Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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 is of child-bearing potential and does not practice medically acceptable methods of contraception. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm study; Subjects swallows the investigational device and undergoes a colonoscopy	Device: Capsule Endoscope; Capsule endoscope used to view colonic mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Percent Agreement/Negative Percent Agreement	Positive Percent Agreement (PPA) of study device (SD) with computer assisted detection (CADe) for detecting the presence in a subject of the largest polyp detected by optical colonoscopy (OC) if that polyp is >= 6mm, where a match is considered to have occurred if a polyp detected by the device is assessed as having a size within plus or minus 50% of the size of the polyp detected by OC and as having a location within the same or an adjacent colon segment.; Negative percent agreement (NPA) of the SD with CADe for not detecting any polyp >= 6mm in a subject for whom OC did not detect any polyp >=6mm.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Percent Agreement/Negative Percent Agreement--secondary	PPA...relying on CADe versus not using CADe for detecting the presence....if that polyp is ≥ 6 mm, where there is a match..; NPA....relying on CADe versus not using CADe for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm.; PPA with CADe for detecting the presence...if that polyp is ≥ 10 mm, where there is a match..; NPA with CADe for not detecting any polyp ≥ 10 mm in a subject for whom OC did not detect any polyp ≥ 10 mm.; Sensitivity with CADe for detecting advanced neoplasia & is assessed to be =>10 mm in size.; Specificity with CADe for not detecting any lesion ≥ 10 mm when OC did not detect any advanced neoplasia.; PPA with CADe if that polyp is ≥ 6 mm and < 10 mm; Sensitivity with CADe for polyp ≥ 6 mm.	6 weeks

Collaborators and Investigators

• Sponsor: Capso Vision, Inc.
• Investigators: Principal Investigator: David Shields, MD, Gastroenterology Consultant at San Mateo County Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): February 14, 2025
• Study Completion (Actual): February 14, 2025

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: CLN-CVI-5794

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No