A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.
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 an Exablate procedure for their planned TDPD treatment; per local institution standard of care.
• Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits
• Subject has signed and received a copy of the approved informed consent form
Locations
United States
Florida
Miami Neuroscience Institute Baptist Health
RECRUITING
Miami
Illinois
Rush University
RECRUITING
Chicago
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
North Carolina
Novant Health Brain & Spine Surgery
RECRUITING
Huntsville
New York
Weill Cornell Medicine
RECRUITING
New York
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Miami Valley Hospital
RECRUITING
Fairborn
Other Locations
United Kingdom
University of Dundee
RECRUITING
Dundee
Contact Information
Primary
Mark Grassman, Ph.D.
markg@insightec.com
214-630-2000
Time Frame
Start Date: 2022-04-28
Estimated Completion Date: 2027-12
Participants
Target number of participants: 50
Treatments
Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease
This is a post Exablate Neuro Thalamotomy registry. No intervention is performed under this registry protocol.
Related Therapeutic Areas
Sponsors
Leads: InSightec