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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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EXPAND Continuation PAS


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General
Study Status Study Pending
Application Number P160013 S002/ PAS001
Date Current Protocol Accepted  
Study Name EXPAND Continuation PAS
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 A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Single-arm, prospective, observational post-approval data collection for subjects enrolled and transplanted in the Lung EXPAND clinical trial. 5-

Year follow-up data will be collected from UNOS for US transplanted patients and directly from the clinical sites in OUS patients
Sample Size All 79 subjects in the Lung EXPAND trial will be re-consented for permission to access to their follow-up data. Only patients who provide

informed consent are enrolled in the Continuation PAS.
Data Collection The primary effectiveness endpoint is Bronchiolitis Obliterans Syndrome (BOS)-free survival (freedom from BOS and mortality) through 5 years

after transplantation.

Other study endpoints include:

Survival (freedom from mortality) through 5 years after transplantation

Freedom from BOS through 5 years after transplantation
Follow-up Visits and Length of Follow-up 5 years


EXPAND Continuation PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/29/2019    
one year report 05/30/2020    
18 month report 11/28/2020    
two year report 05/30/2021    
three year report 05/30/2022    


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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