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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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PAS Registry Study for ExAblate 4000


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General
Study Status Progress Adequate
Application Number P150038 S006/ PAS001
Date Current Protocol Accepted 11/06/2020
Study Name PAS Registry Study for ExAblate 4000
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, multicenter, international single arm, observational post-approval registry study
Study Population Description Single-arm study of male and female patients at least 30 years old who plan to be treated for TDPD using the Exablate Neuro System and who meet the specific enrollment criteria
Sample Size 50 patients are planned for this registry study. From the protocol:

A total of 50 subjects will be enrolled. A t-test graph demonstrated that the power will be sufficient to determine any significant differences in long-term effectiveness at a=0.05. The graph showed that at 25 subjects, the number of subjects needed had plateaued. With an approximate average of an 8% dropout per year through Year 5, the remaining population is estimated to be approximately 30 subjects at year 5, which shows full power.
Data Collection From the protocol:

Safety Analysis

Safety will be evaluated through descriptive analysis of the incidence and severity of adverse events. Adverse events will be recorded and categorized according to severity, expectedness, and relationship to Exablate Neuro system thalamotomy procedure and/or disease progression. Results will be tabulated and reported as follows:

Post thalamotomy incidence and severity of adverse events (AEs).

Comparison of post thalamotomy incidence and severity adverse event rates to the prior Exablate study for ET (PMA #P150038), and TDPD earlier study (P150038/S006).

Comparison of post thalamotomy incidence and severity adverse

events rates to prior Deep Brain Stimulation (DBS) rates

Effectiveness Analysis

Effectiveness will be evaluated through descriptive analysis of ON medication CRST scores for tremor/motor, posture/rest, and level of

disability. Results will be presented as percent change from baseline to post thalamotomy study visits for all subjects where unilateral Exablate

thalamotomy was attempted.
Follow-up Visits and Length of Follow-up 5 years


PAS Registry Study for ExAblate 4000 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Interim report 06/16/2019 07/25/2019 Overdue/Received
Interim report 12/16/2019 12/13/2019 On Time
Interim report 06/15/2020 08/21/2020 Overdue/Received
Interim report 12/15/2020 12/21/2020 Overdue/Received
Interim Report 06/19/2021 07/14/2021 Overdue/Received
three year report 12/15/2021    
four year report 12/15/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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