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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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WP02 Cont Access Long-Term F/u PAS


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General
Study Status Terminated
Application Number /
Requirement Number		 P200035 / PAS002
Date Original Protocol Accepted 12/09/2021
Date Current Protocol Accepted  
Study Name WP02 Cont Access Long-Term F/u PAS
Device Name OrganOx metra System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
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 The WP02 CAP Long-Term Follow-Up PAS is an observational study designed to evaluate the long-term outcomes of patients from the WP02 trial. Outcomes will be evaluated using data from the United Network of Organ Sharing (UNOS) database.
Study Population The subjects of this study will be all of the subjects receiving transplants in the IDE CAP study where UNOS IDs were provided by the site and where subjects have consented to have their information sent to UNOS.
Sample Size Up to 105 of 105 NMP transplants performed (final sample size pending evaluation of the number of patients that have consented to have their information sent to UNOS).
Key Study Endpoints Primary objectives:
To assess graft and subject survival in identified subjects
To assess evidence of biliary complications in identified subjects

Secondary objectives:
To report post-transplant malignancy in identified subjects
To report viral detection in identified subjects
Follow-up Visits and Length of Follow-up Data will be collected on subjects through 36 months post-transplant procedure.




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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