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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

Sponsored by InSightec

About this 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.

This is a post-approval registry which is required by of the approval under PMA P150038/S014 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral pallidotomy in the treatment of idiopathic Parkinson's Disease with medication-refractory moderate to severe motor complications. Subjects participating in this registry will have received a unilateral pallidotomy using the commercially available Exablate Neuro. The following assessments will be collected at Baseline, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years: Adverse Events (AEs) (does not apply to Baseline Visit) Medication usage MDS-UPDRS Unified Dyskinesia Rating Scale EQ-5D-5L WPAI-GH Clinician and Patient Global Impression of Change Patient Satisfaction Questionnaire

Where this study is enrolling (4)

Who can participate

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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Trial data sourced from ClinicalTrials.gov.