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
Recruiting now
Conditions studied: Movement Disorders, Neurology, Parkinsons Disease
In brief
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.
Key facts
- Study ID
- NCT05539196
- Run by
- InSightec
- People needed
- 60
- Starts
- 2023-01-23
- Expected to finish
- 2029-07-31
- Last updated by the study team
- 2026-03-20
Who can join
Age: 30 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.
Where it is running
- University of Maryland, Baltimore — Baltimore, Maryland, United States (enrolling)
- Weill Cornell Medicine — New York, New York, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- Ohnishi Neurological Center — Akashi, Hyōgo, Japan (enrolling)
Full record on ClinicalTrials.gov
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