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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

Recruitingn/aAges 30 Years - 99 YearsAllInSightec
NCT05539196 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Exablate Pallidotomy, Unilateral
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Where

5 sites
University of Maryland, Baltimore
Baltimore, United States
Weill Cornell Medicine
New York, United States
University of Pennsylvania
Philadelphia, United States
University of Texas Southwestern Medical Center
Dallas, United States
Ohnishi Neurological Center
Akashi, Japan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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