Registry for Exablate Neuro treatment in Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, international observational registry that aims to collect data on patients undergoing unilateral pallidotomy using the Exablate Neuro device for advanced Parkinson's Disease with medication-refractory motor complications. The registry will enroll 60 subjects across approximately 10 centers worldwide and will follow participants for 5 years, with assessments at baseline, 3, 6, and 12 months, and annually thereafter. Data collected will include adverse events, medication usage, and various patient-reported outcomes to evaluate the treatment's effectiveness and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Maryland, Baltimore
  Baltimore, Maryland, United States Recruiting
• Weill Cornell Medicine
  New York, New York, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Ohnishi Neurological Center
  Akashi, Hyōgo, Japan Recruiting

Study contacts

• Study coordinator: Kingsley Nwaogu
• Email: clinicalresearchquestions@insightec.com
• Phone: 2143048265

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.