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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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New Enrollment PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P200035 / PAS003
Date Original Protocol Accepted 12/09/2021
Date Current Protocol Accepted 10/27/2023
Study Name New Enrollment PAS
Device Name OrganOx metra System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a multi-site, single arm, unblinded post-approval study comparing prospective recipients of PAS NMP livers versus historical IDE SCS livers
with respect to adverse biliary-related events.

Primary Objective:
To compare the effect of NMP to SCS in the prevention of adverse biliary related events, as measured by biliary complications in subjects that
received a liver from a DBD donor or a DCD donor age less than 40y.

Secondary Objectives:
1) To assess graft survival in new enrollment NMP livers in subjects that receive a liver from a DBD donor or a DCD donor age less than 40y. 2) To
assess subject survival in new enrollment NMP livers in subjects that received a liver from a DBD donor or a DCD donor age less than 40y. 3) To
compare the graft survival rate of subjects that received a liver from a DCD donor age 40y-70y to the graft survival rate of subjects that received a liver from a DCD donor age less than 40y.
Study Population Deceased DBD and DBD donor livers and adult liver transplant recipients more than 40y.
Sample Size 315 transplanted livers, with minimum 40 livers from DCD donors less than 40y and a maximum of 105 livers from DCD donors 40y-70y.
Key Study Endpoints Primary Effectiveness Endpoint:
Adverse biliary-related events as measured by biliary complications at 3-months, 6-months, and 12-months post-transplant.

Secondary Effectiveness Endpoints
Graft survival rates, subject survival rates at 3-months, 6- months, and 12-months post-transplant
Follow-up Visits and Length of Follow-up Patients will be followed and evaluated for outcomes at 3, 6, and 12 months. Outcomes will be analyzed and reported after all available transplanted subjects have completed the 12-month post-transplant follow-up visit.
Interim or Final Data Summary
Actual Number of Patients Enrolled 64
Actual Number of Sites Enrolled 11
Patient Follow-up Rate 39% at 3-month; 25% at 6-month; 16% at 12-month


New Enrollment PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/07/2023 01/04/2023 On Time
1 year report 07/07/2023 07/07/2023 On Time
18 month report 01/07/2024 01/08/2024 Overdue/Received
2 year report 07/07/2024    


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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