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

Conditions

• Colonic Polyps

Eligibility Criteria

Sex

ALL

Age

45 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Capsule swallow — DEVICE
  Participant will swallow the investigational device

Study Details

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

Key Dates

Start date

Jun 26, 2025

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

330 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Arms

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

Primary Outcome Measure

Positive Percentage Agreement [ Time Frame: From capsule swallow to Colonoscopy - up to 6 weeks ]

Central Contacts

• Taylor Williamsen Principle CRA/Study Lead
  815-861-9575
  [email protected]
• Rebecca Petersen Sr. Director of Clinical Affairs
  510-566-8824
  [email protected]

Locations (11)

Find similar trials in Chula Vista, CA