Status:
RECRUITING
A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease
Lead Sponsor:
InSightec
Conditions:
Tremor Associated With Tremor Dominant Parkinson's Disease
Eligibility:
All Genders
30-99 years
Brief Summary
The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.
Detailed Description
This is a post-approval registry which is required by of the approval under PMA P150038/S006 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral thalamotomy in the treat...
Eligibility Criteria
Inclusion Criteria:
- Men and women, age 30 years and older
- Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care.
- Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits
- Subject has signed and received a copy of the approved informed consent form
Exclusion Criteria:
Subject does not agree to participate or is unlikely to participate for the entirety of the study.
Key Trial Info
Start Date :
April 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04991831
Start Date
April 28 2022
End Date
December 1 2027
Last Update
March 20 2026
Active Locations (8)
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1
Miami Neuroscience Institute Baptist Health
Miami, Florida, United States, 33176
2
Rush University
Chicago, Illinois, United States, 60612
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Weill Cornell Medicine
New York, New York, United States, 10065