U.S., July 17 -- ClinicalTrials.gov registry received information related to the study (NCT07069556) titled 'ColoSense Post-Approval Study' on June 27.
Brief 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.
Study Start Date: Sept. 01
Study Type: OBSERVATIONAL
Condition:
Colorectal Cancer (Diagnosis)
Intervention:
DEVICE: ColoSense
multi-target stool RNA test
Recruitment Status: NOT_YET_RECRUITING
Sponsor: Geneoscopy, Inc.
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