Actively 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
Led by InSightec · Updated on 2026-03-20
60
Participants Needed
5
Research Sites
340 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 enroll 60 subjects and will be conducted at approximately 10 centers worldwide.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
5
Ohnishi Neurological Center
Akashi, Hyōgo, Japan, 674-0064
Actively Recruiting
Research Team
K
Kingsley Nwaogu
CONTACT
J
Julia Zhu
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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