Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05539196 | RECRUITING | Movement Disorders

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

Brief 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.

Condition or disease

Movement Disorders

Neurology

Parkinsons Disease

Intervention/treatment

Exablate Pallidotomy, Unilateral

Detailed 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

Study Type : OBSERVATIONAL
Estimated Enrollment : 60 participants
Official Title : 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
Actual Study Start Date : 2023-01-23
Estimated Primary Completion Date : 2029-07-31
Estimated Study Completion Date : 2029-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
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

Location Details

NCT05539196

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Maryland

University of Maryland, Baltimore

Baltimore, Maryland, United States, 21201

RECRUITING

United States, New York

Weill Cornell Medicine

New York, New York, United States, 10065

RECRUITING

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19106

RECRUITING

United States, Texas

University of Texas Southwestern Medical Center

dallas, Texas, United States, 75390

RECRUITING

Japan, Hyōgo

Ohnishi Neurological Center

Akashi, Hyōgo, Japan, 674-0064