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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ColoSense Post-Approval Study


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General
Study Status Study Pending
Application Number /
Requirement Number
P230001 / PAS001
Date Original Protocol Accepted 05/03/2024
Date Current Protocol Accepted 09/09/2024
Study Name ColoSense Post-Approval Study
Device Name ColoSense®
Clinical Trial Number(s) NCT04739722 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study will be a prospective study. Subjects can be enrolled online using decentralized recruitment procedures.
The primary objective is to continue to evaluate the clinical effectiveness of ColoSense by obtaining at least 23 CRC cases (23 cases in addition to the 27 obtained in CRC-PREVENT for a total of 50 CRC cases) to have an adequate number of CRC subjects that are part of the intended use population (average risk) to provide more certainty in the test performance.
The secondary objective of this PAS is to further define sensitivity for colorectal cancer, advanced adenomas, and serrated precancerous lesions and specificity for negative findings on a colonoscopy for Geneoscopy’s multitarget stool RNA test (ColoSense), using colonoscopy as the reference methods.
Study Population Subjects aged 45 years or older, who are at typical average-risk of developing colorectal neoplasms and are considered enrolled after understanding and consenting to ICF.
Inclusion Criteria:
¿ Subject is male or female, =45 years of age
¿ Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form
¿ Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure.
¿ Subject is able and willing to undergo a colonoscopy after providing a stool sample
Exclusion Criteria:
Subjects are not permitted to enroll in the PAS study if any of the following exclusion criteria are met:
¿ Subject had any precancerous findings on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size.
¿ Subject has a history or diagnosis of colorectal cancer
¿ Subject has a history of aerodigestive tract cancer
¿ Subject has had a positive non-invasive screening diagnostic within the
associated recommended intervals:
¿ Fecal occult blood test or fecal immunochemical test within the previous twelve (12) months
¿ FIT-DNA test within the previous 36 months
¿ Subject has had a colonoscopy in the previous nine (9) years.
¿ Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
¿ Indication for colonoscopy was due to overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
¿ Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
¿ Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
¿ Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP)
¿ Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome")
¿ Other hereditary cancer syndromes including but are not limited to:
¦ Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome
¦ Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis
¦ Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis
Sample Size Number of subjects: 12,500 subjects
Assumptions for sample size estimation: an estimate that 65% of enrolled patients would complete all study requirements, approximately 8,125 viable results. This study size is based on estimated observed in the CRC-PREVENT clinical trial (NCT04739722), a CRC incidence of 0.40% (n = 36) including those with a first-degree relative with CRC; and a CRC incidence of 0.30% (n = 27) excluding those with a first-degree relative with CRC. Therefore, with 12,500 enrolled subjects and 8,125 viable subjects, an additional 33 patients with CRC. Of these 33 subjects with CRC, 23 would have no first-degree relative with CRC.
Key Study Endpoints The primary endpoints for this study are ColoSense sensitivity for colorectal cancer, ColoSense sensitivity for advanced adenomas, ColoSense sensitivity for serrated precancerous lesions, and ColoSense specificity for all other findings.
Criteria for success requires that the combined sensitivity of CRC (CRCs observed in the CRC-PREVENT clinical trial and CRCs observed in the PAS) must be greater than 90% and the lower bound of the 95% two-sided confidence interval must be greater than 80%.
The secondary endpoints for this study evaluate ColoSense sensitivity for subsets and supersets of the various histopathological categories.
Follow-up Visits and Length of Follow-up Subjects will be followed annually for a total of 2 years.


ColoSense Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/01/2024 10/31/2024 On Time
1 year report 05/03/2025    
18 month report 11/01/2025    
2 year report 05/03/2026    
3 year report 05/03/2027    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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