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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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 enroll 60 subjects and will be conducted at approximately 10 centers worldwide.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 99
Healthy Volunteers: f
View:
• 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.
Locations
United States
Maryland
University of Maryland, Baltimore
RECRUITING
Baltimore
New York
Weill Cornell Medicine
RECRUITING
New York
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Other Locations
Japan
Ohnishi Neurological Center
RECRUITING
Akashi
Contact Information
Primary
Nadir Alikacem
nadira@insightec.com
+12146302000
Backup
Gaganjot Sooch
gaganjot@insightec.com
+12146302000
Time Frame
Start Date: 2023-01-23
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 60
Treatments
Post Exablate Neuro Pallidotomy for Parkinson's Disease with Motor Complications
The population enrolled in this registry will be comprised of male and female patients that plan to be treated using the Exablate Neuro system for advanced, idiopathic Parkinson's disease with medication-refractory moderate to severe motor complications. No intervention is performed under this registry protocol.
Related Therapeutic Areas
Sponsors
Leads: InSightec