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

Last updated: May 30, 2024
Sponsor: InSightec
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dyskinesias

Neurologic Disorders

Tic Disorders

Treatment

Exablate Pallidotomy, Unilateral

Clinical Study ID

NCT05539196
PD006PAS/PD015
  • Ages 30-99
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Men and women, age 30 years and older.

  • Subject undergoing a planned an Exablate procedure for their Parkinson's Diseasewith Motor Complications per local institution standard of care.

  • Subject is willing to cooperate with the Registry requirements including compliancewith the regimen and completion of all Registry visits.

  • Subject has signed and received a copy of the approved informed consent form.

Exclusion

Exclusion Criteria:

  • Subject does not agree to participate or is unlikely to participate for the entiretyof the Registry.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Exablate Pallidotomy, Unilateral
Phase:
Study Start date:
January 23, 2023
Estimated Completion Date:
July 31, 2029

Study Description

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

Connect with a study center

  • Ohnishi Neurological Center

    Akashi, Hyogo 674-0064
    Japan

    Active - Recruiting

  • University of Maryland, Baltimore

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19106
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

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