NCT05539196Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 12 Sept 2022
- Start date
- 23 Jan 2023
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- InSightec
- Diseases
- Parkinson disease
- NCT number
- NCT05539196
What you commit to
- Study type: Observational
- Planned participants: 60
- From 23 Jan 2023 to the primary completion date, 31 Jul 2029
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.
Who the study is looking for
- 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.
Age in the registry: 30 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohnishi Neurological Center Coordinator of this site? Confirm its status | Akashi | Japan | Recruiting |
| University of Maryland, Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.