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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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ExAblate Neuro PAS


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General
Study Status Study Pending
Application Number /
Requirement Number
P150038 S014/ PAS001
Date Original Protocol Accepted 06/30/2022
Date Current Protocol Accepted 07/29/2022
Study Name ExAblate Neuro PAS
Device Name Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives The objectives of this Registry are:
Collect the safety and effectiveness data of performing pallidotomy for Parkinson’s Disease Motor Complications using the Exablate Neuro system through Year 5.
This is a post-approval registry which is required by the approval under PMA P150038/S014 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral pallidotomy in the treatment of advanced, idiopathic Parkinson’s disease with medication-refractory moderate to severe motor complications as an adjunct to Parkinson’s disease medication treatment. This protocol will enroll approximately 60 new subjects as Cohort 2. Cohort 1 includes the long-term follow-up from the G170237 IDE which will continue to Year 5
Study Population The population enrolled in this registry will be comprised of male and female patients that plan to be treated using the Exablate Neuro system for advanced, idiopathic Parkinson’s disease with medication-refractory moderate to severe motor complications
1. Men and women, age 30 years and older
2. Subject undergoing a planned an Exablate procedure for their Parkinson’s Disease with Motor Complications per local institution standard of care.
3. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry visits
4. Subject has signed and received a copy of the approved informed consent form
This is a single arm study, which is no comparison group.
Sample Size The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide.
Key Study Endpoints 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 pallidotomy procedure and/or disease progression. Results will be tabulated and reported as follows:
• Post pallidotomy incidence and severity of adverse events (AEs).
• Comparison of post pallidotomy incidence and severity of adverse event rates to the prior Exablate Registry for PD (PMA #P150038/S014).
• Comparison of post pallidotomy incidence and severity of adverse events rates to Deep Brain Stimulation (DBS) rates as reported in the literature
Primary Effectiveness will be evaluated through a Responder analysis. Responder is defined as the patient reaching a minimally clinically significant difference on:
• UDysRS Objective Assessment ON Meds, without clinically significant worsening of MDS-UPDRS Part III OFF Meds aggregated extremity score for treated side
• 2) MDS-UPDRS Part III OFF Meds Motor Exam on the treated side, without clinically significant worsening of UDysRS Objective Assessment ON meds
Minimally clinically important difference for this Registry is defined as follows:
• Control of dyskinesia will be captured using the UDysRS Objective assessment ON meds. A Responder will be identified as Improvement by more than 3 points (lower score than Baseline) and Worsening will be identified as more than 3 points higher (compared to Baseline).
• Control of bradykinesia will be captured by Off meds state MDS-UPDRS Part III aggregated extremity questions for treated side. A Responder will be identified as at least 3 or more points Improvement (lower score than Baseline). Worsening is defined as at least 4 points or more higher (compared to Baseline) Additional Data.
Additional data, including but not limited to, demographics, change from baseline to all Registry visits of each MDS-UPDRS (Parts I, II, III OFF, IV), UDysRS, CGIC, PGIC, patient satisfaction questionnaire may be compiled.
Follow-up Visits and Length of Follow-up 5 years


ExAblate Neuro PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/29/2022 05/03/2022 Overdue/Received
1 year report 10/29/2022   Overdue
18 month report 04/29/2023    
2 year report 10/29/2023    
3 year report 10/28/2024    


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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