Trials / Recruiting
RecruitingNCT07069556
ColoSense Post-Approval Study
ColoSense Post Approval Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 12,500 (estimated)
- Sponsor
- Geneoscopy, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The post-approval study (PAS) described here will supplement existing data generated in the CRC-PREVENT clinical trial. The primary outcomes of this supplemental study will include: clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV) of ColoSense.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ColoSense | multi-target stool RNA test |
Timeline
- Start date
- 2025-09-05
- Primary completion
- 2028-09-01
- Completion
- 2030-09-01
- First posted
- 2025-07-16
- Last updated
- 2025-11-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07069556. Inclusion in this directory is not an endorsement.