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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exablate Pallidotomy, Unilateral.
- Who it may be relevant to
- Registry conditions: Movement Disorders, Neurology, Parkinsons Disease. Basic parameters: 30 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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
Interventions
- Device Exablate Pallidotomy, Unilateral
Unilateral pallidotomy using focused ultrasound for the treatment of Parkinson's Disease with medication-refractory moderate to severe motor complications.
Primary outcome measures
- Responder Analysis [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- University of Maryland, Baltimore — Baltimore
- Weill Cornell Medicine — New York
- University of Pennsylvania — Philadelphia
- University of Texas Southwestern Medical Center — Dallas
Japan · 1 center
- Ohnishi Neurological Center — Akashi
Identifiers
NCT: NCT05539196 · PD006PAS/PD015