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

NCT04607746 | Completed FDA Device

• 1 other identifier: CLN-CVI-5794
• Study Type: interventional
• Target: 1,337
• Locations: 1 country
• Sites: 23

Brief Summary

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

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (1)

• Positive Percent Agreement/Negative Percent Agreement

  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.

  6 weeks

Secondary Outcomes (1)

• Positive Percent Agreement/Negative Percent Agreement--secondary

  6 weeks

Study Arms (1)

Single arm study

EXPERIMENTAL

Subjects swallows the investigational device and undergoes a colonoscopy

Device: Capsule Endoscope

Interventions

Capsule Endoscope DEVICE

Capsule endoscope used to view colonic mucosa

Single arm study

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 45-75 years of age
• Committed to undergo a colonoscopy, independent of this study
• Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor

You may not qualify if:

• Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
• Has contraindication for capsule endoscopy or colonoscopy
• Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
• Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
• History of incomplete colonoscopy
• 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.)
• Impaired cardiac function assessed as greater than NYHA Class II
• History of small- or large-bowel obstructive condition
• Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
• 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
• Known allergy to ingredients used in bowel preparation and boosters
• Daily and/or regular narcotic use
• Decompensated cirrhosis
• Prior abdominal radiation therapy
• Diagnosis of anorexia or bulimia

Sponsors & Collaborators

• Capso Vision, Inc.: lead

Study Sites (23)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Gastro Care Institute

Lancaster, California, 93534, United States

Location

inSite Digestive Health Care

Los Gatos, California, 95032, United States

Location

Knowledge Research Center

Orange, California, 92868, United States

Location

Kaiser Permanente Northern California

San Leandro, California, 94577, United States

Location

Advanced Research Institute

New Port Richey, Florida, 34653, United States

Location

Digestive and Liver Center of Florida

Orlando, Florida, 32825, United States

Location

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684, United States

Location

Advanced Research Institute

St. Petersburg, Florida, 33710, United States

Location

Digestive Health Services

Downers Grove, Illinois, 60515, United States

Location

Northshore Center for Gastroenterology

Libertyville, Illinois, 60048, United States

Location

Suburban Gastroenterology

Naperville, Illinois, 60540, United States

Location

Southwest Gastroenterology

New Lenox, Illinois, 60451, United States

Location

Digestive Health Specialists

Chelmsford, Massachusetts, 01824, United States

Location

West Michigan Clinical Research Center

Wyoming, Michigan, 49519, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hattiesburg GI Associates

Hattiesburg, Mississippi, 39402, United States

Location

NY total Medical Care, PC

Brooklyn, New York, 11215, United States

Location

Gastroenterology Group of Rochester

Rochester, New York, 14618, United States

Location

Great Lakes Gastroenterology Research

Mentor, Ohio, 44060, United States

Location

Tri-Cities Gastroenterology

Kingsport, Tennessee, 37663, United States

Location

Vilo Research Group

Houston, Texas, 77017, United States

Location

Gastroenterology Consultants of SW Virginia

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

Capsule Endoscopes

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopes, Gastrointestinal; Endoscopes; Diagnostic Equipment; Equipment and Supplies

Study Officials

• David Shields, MD

  Gastroenterology Consultant at San Mateo County Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Data collected from this study investigated the first generation CV-3 capsule.

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 29, 2020
• Study Start: January 6, 2021
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)