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
1 other identifier
observational
60
2 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2023
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
September 14, 2022
CompletedStudy Start
First participant enrolled
January 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
March 20, 2026
March 1, 2026
6.5 years
September 12, 2022
March 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Responder Analysis
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
5 years
Other Outcomes (1)
Safety Analysis
5 years
Study Arms (1)
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.
Interventions
Unilateral pallidotomy using focused ultrasound for the treatment of Parkinson's Disease with medication-refractory moderate to severe motor complications.
Eligibility Criteria
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. Subjects must meet the specific eligibility criteria in order to enroll in this Registry.
You may qualify if:
- 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.
You may not qualify if:
- Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InSighteclead
Study Sites (5)
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
Weill Cornell Medicine
New York, New York, 10065, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19106, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Ohnishi Neurological Center
Akashi, Hyōgo, 674-0064, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2022
First Posted
September 14, 2022
Study Start
January 23, 2023
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
July 31, 2029
Last Updated
March 20, 2026
Record last verified: 2026-03