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

Not Applicable
Completed
Conditions
Colonic Polyp
Registration Number
NCT04607746
Lead Sponsor
Capso Vision, Inc.
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1337
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Positive Percent Agreement/Negative Percent Agreement6 weeks

1. 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.

2. 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.

Secondary Outcome Measures
NameTimeMethod
Positive Percent Agreement/Negative Percent Agreement--secondary6 weeks

1. PPA...relying on CADe versus not using CADe for detecting the presence....if that polyp is ≥ 6 mm, where there is a match..

2. 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.

3. PPA with CADe for detecting the presence...if that polyp is ≥ 10 mm, where there is a match..

4. NPA with CADe for not detecting any polyp ≥ 10 mm in a subject for whom OC did not detect any polyp ≥ 10 mm.

5. Sensitivity with CADe for detecting advanced neoplasia \& is assessed to be =\>10 mm in size.

6. Specificity with CADe for not detecting any lesion ≥ 10 mm when OC did not detect any advanced neoplasia.

7. PPA with CADe if that polyp is ≥ 6 mm and \< 10 mm

8. Sensitivity with CADe for polyp ≥ 6 mm.

Trial Locations

Locations (21)

inSite Digestive Health Care

🇺🇸

Los Gatos, California, United States

Knowledge Research Center

🇺🇸

Orange, California, United States

Digestive and Liver Center of Florida

🇺🇸

Orlando, Florida, United States

Advanced Gastroenterology Associates, LLC

🇺🇸

Palm Harbor, Florida, United States

Digestive Health Specialists

🇺🇸

Chelmsford, Massachusetts, United States

NY total Medical Care, PC

🇺🇸

Brooklyn, New York, United States

Vilo Research Group

🇺🇸

Houston, Texas, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Gastro Care Institute

🇺🇸

Lancaster, California, United States

Kaiser Permanente Northern California

🇺🇸

San Leandro, California, United States

Scroll for more (11 remaining)
inSite Digestive Health Care
🇺🇸Los Gatos, California, United States

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