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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-Post ExAblate Pregnancy Outcomes Registry


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General
Study Status Progress Inadequate
Application Number P040003 S015/ PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-Post ExAblate Pregnancy Outcomes Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an observational registry study for patients who undergo ExAblate treatment, to collect data about the effect of ExAblate treatment on potential pregnancy occurrences in this population for two years post-treatment for purposes of labeling updates and overall safety data collection.
Study Population Description All consented patients from all participating sites who receive an ExAblate procedure or have previously undergone an ExAblate procedure for symptomatic uterine fibroids will be recruited for this registry.
Sample Size The registry is open to all who would consent at participating sites, and will be open for enrollment for two years. The study aims to enroll up to 200 patients in total. A minimum of ten sites from around the world will participate, including a minimum of six sites from the U.S.
Data Collection Main safety endpoint: Adverse events related to pregnancies, including but not limited to pregnancy outcome, and post-partum complications for the mother and infant. The nature of each adverse event, date and time (when appropriate) of onset, outcome, frequency, maximum intensity, action taken, expectedness, and causal relationship will be recorded.
Follow-up Visits and Length of Follow-up Up to two years after ExAblate treatment, or until pregnancy completion.



Sites should contact the subject 2 times a year (approximately every 6 months) for 2 years after the ExAblate procedure.


OSB Lead-Post ExAblate Pregnancy Outcomes Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/29/2016 03/07/2016 Overdue/Received
one year report 08/30/2016 08/25/2016 On Time
18 month report 02/28/2017 03/03/2017 Overdue/Received
two year report 08/30/2017 09/08/2017 Overdue/Received
three year report 08/30/2018    
four year report 08/30/2019    
five year report 08/29/2020    


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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