Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference
Public ClinicalTrials.gov record NCT07089615. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective, Open Label, Pivotal Study of the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07089615
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 330 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 45 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 25, 2025
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
- Last update posted
- May 7, 2026
2025 – 2026
United States locations
- U.S. sites
- 11
- U.S. states
- 5
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SB Gastro Clinical Research | Chula Vista | California | 91910 | Recruiting |
| Gastro Care Institute | Lancaster | California | 93534 | Recruiting |
| Knowledge Research Center | Orange | California | 92868 | Recruiting |
| Advanced Research Institute | St. Petersburg | Florida | 33710 | Recruiting |
| Digestive Health Services | Downers Grove | Illinois | 60515 | Recruiting |
| Gastroenterology and Internal Medicine Specialists | Lake Barrington | Illinois | 60010 | Recruiting |
| Northshore Center for Gastroenterology | Libertyville | Illinois | 60048 | Recruiting |
| Suburban Gastroenterology | Naperville | Illinois | 60540 | Recruiting |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453 | Recruiting |
| Gastroenterology Group of Rochester | Rochester | New York | 14618 | Recruiting |
| Great Lakes Gastroenterology Research | Mentor | Ohio | 44060 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07089615, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 7, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07089615 live on ClinicalTrials.gov.