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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
NCT05539196 · InSightec
In plain English
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About this study
This is a post-approval registry which is required by of the approval under PMA P150038/S014 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral pallidotomy in the treatment of idiopathic Parkinson's Disease with medication-refractory moderate to severe motor complications. Subjects participating in this registry will have received a unilateral pallidotomy using the commercially available Exablate Neuro.
The following assessments will be collected at Baseline, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years:
Adverse Events (AEs) (does not apply to Baseline Visit) Medication usage MDS-UPDRS Unified Dyskinesia Rating Scale EQ-5D-5L WPAI-GH Clinician and Patient Global Impression of Change Patient Satisfaction Questionnaire
Eligibility criteria
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.
Study design
Enrollment target: 60 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-01-23
Estimated completion: 2029-07-31
Last updated: 2026-03-20
Interventions
Device: Exablate Pallidotomy, Unilateral
Primary outcomes
- • Responder Analysis (5 years)
Sponsor
InSightec · industry
Contacts & investigators
ContactKingsley Nwaogu · contact · clinicalresearchquestions@insightec.com · 2143048265
ContactJulia Zhu · contact · clinicalresearchquestions@insightec.com · 2148462577
All locations (5)
University of Maryland, BaltimoreRecruiting
Baltimore, Maryland, United States
Weill Cornell MedicineRecruiting
New York, New York, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Ohnishi Neurological CenterRecruiting
Akashi, Hyōgo, Japan