Trials / Completed
CompletedNCT04607746
Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
Prospective Open Label, Pivotal Study of the Accuracy of The CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,337 (actual)
- Sponsor
- Capso Vision, Inc. · Industry
- Sex
- All
- Age
- 45 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps.
Detailed description
The first phase of the study investigated the first generation of the capsule. The second generation capsule will be investigated in the final phase of enrollment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Capsule Endoscope | Capsule endoscope used to view colonic mucosa |
Timeline
- Start date
- 2021-01-06
- Primary completion
- 2025-02-14
- Completion
- 2025-02-14
- First posted
- 2020-10-29
- Last updated
- 2025-07-08
Locations
23 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04607746. Inclusion in this directory is not an endorsement.