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

NCT07089615 | Recruiting FDA Device

• 1 other identifier: CLN-CVI-5794 2nd Generation
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 11

Brief 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. 1.prep for and swallow a study capsule and then
2. 2.prep for and undergo a colonoscopy either the following day or 3-6 weeks later

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (2)

• Positive Percentage Agreement

  • Positive Percent Agreement (PPA) of the study device 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 ≥ 6 mm, 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.

  From capsule swallow to Colonoscopy - up to 6 weeks

• Negative Percentage Agreement

  • Negative percent agreement (NPA) of the study device with CADe for not detecting any polyp ≥ 6 mm in a subject for whom OC did not detect any polyp ≥ 6 mm.

  From Capsule swallow to colonoscopy - Up to 6 weeks

Study Arms (1)

A new capsule design is being used from that of the first phase of the study.

EXPERIMENTAL

Device: Capsule swallow

Interventions

Capsule swallow DEVICE

Participant will swallow the investigational device

A new capsule design is being used from that of the first phase of the 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:

• years of age
• Committed to undergo a colonoscopy.
• 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 (11)

SB Gastro Clinical Research

Chula Vista, California, 91910, United States

RECRUITING

Gastro Care Institute

Lancaster, California, 93534, United States

RECRUITING

Knowledge Research Center

Orange, California, 92868, United States

RECRUITING

Advanced Research Institute

St. Petersburg, Florida, 33710, United States

RECRUITING

Digestive Health Services

Downers Grove, Illinois, 60515, United States

RECRUITING

Gastroenterology and Internal Medicine Specialists

Lake Barrington, Illinois, 60010, United States

RECRUITING

Northshore Center for Gastroenterology

Libertyville, Illinois, 60048, United States

RECRUITING

Suburban Gastroenterology

Naperville, Illinois, 60540, United States

RECRUITING

Southwest Gastroenterology

Oak Lawn, Illinois, 60453, United States

RECRUITING

Gastroenterology Group of Rochester

Rochester, New York, 14618, United States

RECRUITING

Great Lakes Gastroenterology Research

Mentor, Ohio, 44060, United States

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

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

Study Officials

• Suejin Kim Study PI, M.D.

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

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

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 28, 2025
• Study Start: June 26, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)