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ColoSense Post-Approval Study

NCT07069556 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 12500

Last updated 2025-11-21

No results posted yet for this study

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

  • Colorectal Cancer (Diagnosis)

Interventions

DEVICE

ColoSense

multi-target stool RNA test

Sponsors & Collaborators

  • Geneoscopy, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2028-09-01
Completion
2030-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069556 on ClinicalTrials.gov