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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-Long-Term Study


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General
Study Status Progress Adequate
Application Number H120003 / PAS001
Date Current Protocol Accepted 04/10/2015
Study Name OSB Lead-Long-Term Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this study is to demonstrate the XVIVO Perfusion System (XPS) with STEEN Solution can be safely used for the flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the function of the lungs can be reassessed for transplantation. The study is a prospective, multicenter, controlled clinical trial.

Study Population Description A total of 252 patients will include 220 from the premarket cohort and 32 newly enrolled patients. The treatment arm will consist of 126 who receive EVLP treated lungs that were initially unacceptable and the comparator arm will consist of 126 patients who are transplanted with standard lungs that are preserved with the cold storage method.

Sample Size A total of 252 patients (126 per arm) will be included in the PAS.
Data Collection The primary endpoint is 3 year survival rate. The secondary endpoints are quality of life, episodes of rejection per United Network for Organ Sharing (UNOS) registry, and Forced Expiratory Volume in 1 second (FEV1) at 1, 2, 3 years. Safety endpoint is the post transplant events captured in the UNOS Registry at 2, 3 years.
Follow-up Visits and Length of Follow-up 3 years (2nd and 3rd year with the UNOS Registry)

Subjects will be followed for 3 years post transplant, with data collected at the 1, 2, and 3 year time points.


OSB Lead-Long-Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/10/2015 02/11/2015 Overdue/Received
one year report 08/12/2015 08/12/2015 On Time
18 month report 02/10/2016 02/25/2016 Overdue/Received
two year report 08/11/2016 08/12/2016 Overdue/Received
three year report 08/11/2017 08/15/2017 Overdue/Received
four year report 08/11/2018    
five year report 08/11/2019    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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