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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WP01 Long-Term Follow-up PAS


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General
Study Status Ongoing
Application Number /
Requirement Number
P200035 / PAS001
Date Original Protocol Accepted 12/09/2021
Date Current Protocol Accepted 04/12/2022
Study Name WP01 Long-Term Follow-up PAS
Device Name OrganOx metra System
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study is a continued follow-up of patients from the premarket WP01 clinical 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 the subjects receiving transplants in the WP01 IDE 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 136 of 136 NMP transplants performed and up to 129 of 130 SCS 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.



WP01 Long-Term Follow-up PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 02/28/2022 02/28/2022 On Time
18 month report 10/26/2022 10/21/2022 On Time
2 year report 02/28/2023    
final report 05/31/2023    


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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