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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- InSightec
- Enrollment
- 60
- Locations
- 5
- Primary Endpoint
- Responder Analysis
Study Overview
Brief 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.
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 30 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Exablate Pallidotomy, Unilateral (Device)
Outcomes
Primary Outcomes
Responder Analysis
Time Frame: 5 years
Primary Effectiveness will be evaluated through a Responder analysis. Responder is defined as the patient reaching a minimally clinically significant difference on: 1) UDysRS Objective Assessment ON Meds, without clinically significant worsening of MDS-UPDRS Part III OFF Meds aggregated extremity score for treated side Or 2) MDS-UPDRS Part III OFF Meds Motor Exam on the treated side, without clinically significant worsening of UDysRS Objective Assessment ON meds
Secondary Outcomes
No secondary outcomes reported