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

Description

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.

Conditions

Movement Disorders, Neurology, Parkinsons Disease

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Movement Disorders
Intervention / Treatment

-

Contacts and Locations

Baltimore

University of Maryland, Baltimore, Baltimore, Maryland, United States, 21201

New York

Weill Cornell Medicine, New York, New York, United States, 10065

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19106

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.

Ages Eligible for Study

30 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

InSightec,

Study Record Dates

2029-07-31