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 · NCT05539196 · Observational (researchers observe without assigning treatment) · Lead sponsor: InSightec
View the official record on ClinicalTrials.gov →Interventions studied
Exablate Pallidotomy, Unilateral
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.
Who can take part
Age range
30 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
5 locations listed across 4 US states.
- University of Maryland, Baltimore - Baltimore, Maryland, United States
- Weill Cornell Medicine - New York, New York, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- Ohnishi Neurological Center - Akashi, Hyōgo, Japan