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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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EMPROVE Extension Study


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General
Study Status Study Pending
Application Number P180007 / PAS001
Date Current Protocol Accepted  
Study Name EMPROVE Extension Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is designed as continued, prospective, long-term follow up of the EMPROVE pre-market cohorts. The objective is to evaluate the long-term safety and effectiveness of the Spiration Valve System for the treatment of severe emphysema. This will be an observational study for long-term follow-up of the EMPROVE Trial pre-market patient cohort with no planned interventions
Study Population Description All active (enrolled and not withdrawn) subjects continuing long-term (beyond 1 year) follow-up in protocol CPR-03434.
Data Collection Primary Safety:

All serious adverse events and non-serious adverse events related to the device or procedure will be assessed at annual follow-up visits by seriousness, severity, and relatedness.



Effectiveness Observations:

The following effectiveness assessments will be undertaken at annual follow-up visits:

Spirometry

St. George’s Respiratory Questionnaire (SGRQ)

SF-36

COPD Assessment Test (CAT)

Modified Medical Research Council dyspnea scale (mMRC)

Quality of Well Being (QWB) questionnaire



Follow-up Visits and Length of Follow-up Control group subjects will be followed annually through 2 years.

Treatment group subjects will be followed annually through 5 years.

a1 antitrypsin deficiency subjects (a separate non-randomized treatment cohort) will be followed annually through 5 years.



EMPROVE Extension Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 12/03/2019    
two year report 12/02/2020    
three year report 12/02/2021    
four year report 12/02/2022    


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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