Status:
RECRUITING
A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications
Lead Sponsor:
InSightec
Conditions:
Movement Disorders
Neurology
Eligibility:
All Genders
30-99 years
Brief Summary
This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will...
Detailed Description
This is a post-approval registry which is required by of 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 treat...
Eligibility Criteria
Inclusion Criteria:
- Men and women, age 30 years and older.
- Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care.
- Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry 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 Registry.
Key Trial Info
Start Date :
January 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05539196
Start Date
January 23 2023
End Date
July 31 2029
Last Update
March 20 2026
Active Locations (5)
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1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
2
Weill Cornell Medicine
New York, New York, United States, 10065
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390