RecruitingNCT05539196

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


Sponsor

InSightec

Enrollment

60 participants

Start Date

Jan 23, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This registry is collecting follow-up data on patients who undergo a procedure called focused ultrasound pallidotomy (using the Exablate 4000 device) for advanced Parkinson's disease. The procedure uses sound waves to precisely destroy a small area of the brain (the globus pallidus) that causes tremors, stiffness, and movement complications when medications stop working well. This is a post-market registry — the device is already approved — and the study is tracking long-term outcomes. **You may be eligible if:** - You are 30 years or older - You have idiopathic (typical) Parkinson's disease with significant motor complications (tremors, dyskinesia) not adequately controlled by medication - Your doctor has already planned or is performing an Exablate focused ultrasound procedure as standard care - You are willing and able to attend all follow-up visits **You may NOT be eligible if:** - You are unwilling to participate for the full duration of the registry Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExablate Pallidotomy, Unilateral

Unilateral pallidotomy using focused ultrasound for the treatment of Parkinson's Disease with medication-refractory moderate to severe motor complications.


Locations(5)

University of Maryland, Baltimore

Baltimore, Maryland, United States

Weill Cornell Medicine

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Ohnishi Neurological Center

Akashi, Hyōgo, Japan

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NCT05539196


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