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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

Who can join

Ages 30 to 99 · All sexes

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.

About the study

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.

What is being tested

• Exablate Pallidotomy, Unilateral (device)

Sponsor: InSightec · Participants: 60 · Started: Jan 23, 2023

Contact the study team

• Kingsley Nwaogu · Phone: 2143048265
• Julia Zhu · Phone: 2148462577

Official record on ClinicalTrials.gov — NCT05539196

Locations in the U.S.

Conditions

• Movement Disorders
• Parkinson's Disease

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.