f Post-Approval Studies (PAS) Database
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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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The Patient Exposure Study


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General
Study Status Delayed
Application Number /
Requirement Number		 P200029 / PAS001
Date Original Protocol Accepted 05/14/2021
Date Current Protocol Accepted 12/02/2022
Study Name The Patient Exposure Study
Device Name TheraSphere
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives To calculate the radiation-absorbed dose of Technetium-99m macroaggregated albumin (Tc-99m MAA).
Study Population Patients who are being evaluated for TheraSphere administration.
Sample Size 5 PT, up to 3 sites
Key Study Endpoints Mean absorbed dose (Gy) and activity (Bq) will be summarized for the whole body and for critical non-liver organs (including whole body effective dose).
Follow-up Visits and Length of Follow-up 3 times within 24 hours
Interim or Final Data Summary
Actual Number of Patients Enrolled 4
Actual Number of Sites Enrolled 1


The Patient Exposure Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/15/2021 09/14/2021 On Time
1 year report 03/17/2022 03/16/2022 On Time
18 month report 09/15/2022 09/14/2022 On Time
2 year report 03/17/2023 03/16/2023 On Time
final report 09/29/2023 11/02/2023 Overdue/Received


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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