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NCT05539196 · ClinicalTrials.gov record · last posted 2026-03-20

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

StatusRecruiting
PhaseNot specified
SponsorInSightec
Started2023-01-23
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from the ClinicalTrials.gov record
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.

Amendment record 9 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 9 times since 2022-09-12; most recent amendment 2026-03-18. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-02-02
Status change Not Yet Recruiting→Recruitingv3
Trial Details
NCT Number NCT05539196
Lead Sponsor InSightec
Conditions Movement Disorders, Neurology, Parkinsons Disease
Enrollment 60 participants
Start Date 2023-01-23
Primary Completion 2029-07-31 (estimated)
Study Completion 2029-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-20