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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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Shield Post-Approval Study


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General
Study Status Study Pending
Application Number /
Requirement Number
P230009 / PAS001
Date Original Protocol Accepted 09/20/2024
Date Current Protocol Accepted  
Study Name Shield Post-Approval Study
Device Name Shield
Clinical Trial Number(s) NCT04136002 
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 The Shield post-approval study (PAS) is a prospective, longitudinal study supplemented with Real World Evidence (RWE).

The study objective is to collect longitudinal data on subjects who receive the Shield test for colorectal cancer screening at two consecutive screening intervals and evaluate performance measures of the test at the second interval using colonoscopy as the reference method.
Study Population Subjects between the ages of 45 and 81 at average risk of CRC
Sample Size Number of subjects: 3,375
Assumptions for sample size estimation:
Based on the expected prevalence of CRC (0.4%-0.7%) and targeted sample size for CRC established below, a total of at least 3375 subjects confirmed without a CRC diagnosis are expected to be available with a valid negative Shield test result at T0. Assuming T3 AA prevalence is at least 7% and non-AN prevalence is at least 88%, there will be at least 70 T3 AA subjects and at least 880 T3 non-AN subjects. Based on 70 AA subjects and 880 non-AN subjects, the half-width of the two-sided 95% confidence interval of AA sensitivity and AN specificity are expected to be within 8% and 2%, respectively, assuming AA sensitivity is 13%, and AN specificity is 90%.
Number of sites: 40 sites
Sites location: US.
Key Study Endpoints Co-Primary performance measures:
• Sensitivity for CRC, AA, and specificity for non-advanced neoplasia at T3.
• Positive predictive value (PPV) for CRC, AA and advanced neoplasia at T3.
• Negative predictive value (NPV) for CRC and advanced neoplasia at T3.

Secondary performance measures:
• Cumulative risk of false positive result (cFPR) and cumulative risk of a true positive result (cTPR)
• Probability that a negative Shield result at baseline remains negative through 3 years
• Probability that a negative Shield result at baseline (T0) results in no CRC through 3 years
• Distribution of colorectal epithelial lesions (by Category) among positive Shield subjects at T0 and at T3
• Adherence to repeat Shield at T3
• Compliance to colonoscopy following a positive T0 Shield result
• Cross-over to alternative screening methodologies (e.g., FOBT, colonoscopy, other) from T0 to T3
• The rate of no Shield result (e.g., invalid result)
• Supplemental real world evidence study to evaluate PPV at T0 and T3
Follow-up Visits and Length of Follow-up Patients will receive Shield test at T0 and T3. Colonoscopy will be performed for patients with positive Shield test and all patients at T3. Real-world evidence will be used to supplement the two years (T1 and T2) between T0 and T3 and the one year directly after T3 (T3-T4). Enrolled participant data will be gathered to not only follow participants between points of care for disease onset and/or progression but also to mitigate for data resulting from lost-to-follow-up or incomplete events using claims history in the T3-T4 period


Shield Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/24/2025 01/22/2025 On Time
1 year report 07/26/2025    
18 month report 01/24/2026    
2 year report 07/26/2026    
3 year report 07/26/2027    
4 year report 07/25/2028    
5 year report 07/25/2029    


Contact Us

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

Additional Resources

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