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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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DBS for Epilepsy New Enrollment PAS


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General
Study Status Study Pending
Application Number P960009 S219/ PAS001
Date Current Protocol Accepted 07/24/2019
Study Name DBS for Epilepsy New Enrollment PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study will be a new enrollment single-arm study design to evaluate clinical outcomes of safety and effectiveness in subjects treated with the DBS device + current medical management (CMM) following an initial period of 3 months of CMM only. Subjects will then be clinically eligible for the DBS device + CMM. Those meeting implant criteria will undergo DBS implant +CMM.
Study Population Description The intended study population is subjects 18 years and older diagnosed with epilepsy characterized by focal-onset seizures that are refractory to at least 3 AEDs.
Sample Size A total of 216 subjects will be enrolled in the study to ensure that at least 140 subjects will be implanted with the DBS device and at least 112 subjects will have data through 3 years of follow-up.
Data Collection The primary effectiveness endpoint is the median percentage reduction in seizures (of at least 40%) from pre-implant to post- implant in subjects treated with the DBS system at 36 months.

The primary safety endpoint is a measure of the total seizure frequency (not a 20% worsening) over time in subjects treated with the DBS system beginning at DBS + CMM Months 6-12 and extending through DBS + CMM Year 3.
Follow-up Visits and Length of Follow-up 3 years


DBS for Epilepsy New Enrollment PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/26/2018 10/22/2018 On Time
one year report 04/27/2019 04/11/2019 On Time
18 month report 10/26/2019    
30 month report 10/26/2020    
three year report 04/26/2021    
four year report 04/26/2022    
five year report 04/26/2023    


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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