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NCT07089615 · ClinicalTrials.gov registry record · NA
Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference
A NA study of Colonic Polyps, sponsored by Capso Vision.
- Recruiting
- Registry status
- NA
- Development phase
- 330
- Enrollment target
- 11
- Study locations
NCT07089615: Recruiting NA study of Colonic Polyps, sponsored by Capso Vision.
NCT07089615 is a NA study of Colonic Polyps that is actively recruiting participants, run by Capso Vision. The registered enrollment target is 330 participants, below the 735-participant average among 6 other Colonic Polyps trials with a reported enrollment target (55% lower). The trial reports 11 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07089615, a NA study of Colonic Polyps, is actively recruiting participants, sponsored by Capso Vision.
- RECRUITING
- Registry status
- NA
- Development phase
- 330 participants
- Enrollment target
- 11
- Study locations
Study 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. 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
Primary Outcome
• 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.
Conditions Studied
Interventions
- DEVICE Capsule swallow
Study Locations (11)
Illinois
- Digestive Health Services - Downers Grove
- Gastroenterology and Internal Medicine Specialists - Lake Barrington
- Northshore Center for Gastroenterology - Libertyville
- Suburban Gastroenterology - Naperville
- Southwest Gastroenterology - Oak Lawn
California
- SB Gastro Clinical Research - Chula Vista
- Gastro Care Institute - Lancaster
- Knowledge Research Center - Orange
Florida
- Advanced Research Institute - St. Petersburg
New York
- Gastroenterology Group of Rochester - Rochester
Ohio
- Great Lakes Gastroenterology Research - Mentor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2025-06-26 |
| Est. Completion | 2026-01 |
| Phase | NA |
What NCT07089615 shows while recruiting
NCT07089615 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 735-participant average among 6 other Colonic Polyps trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Colonic Polyps appearing as the primary indexed condition, and to 1 intervention - of which Capsule swallow is the first listed.
NCT07089615 lists 11 locations in 5 states (Illinois, California, Florida).
Frequently Asked Questions
What is clinical trial NCT07089615 about?
NCT07089615 is a clinical study titled "Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference". 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...
What is the current status of trial NCT07089615?
This trial is currently recruiting. It is a NA study. The enrollment target is 330 participants. The study started on 2025-06-26. Estimated completion is 2026-01.
What conditions does trial NCT07089615 study?
This clinical trial studies the following conditions: Colonic Polyps.
What interventions are being tested in trial NCT07089615?
The interventions under investigation include: Capsule swallow (DEVICE).
Who is sponsoring clinical trial NCT07089615?
This trial is sponsored by Capso Vision, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07089615 being conducted?
This trial has 11 study locations across California, Florida, Illinois, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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