RecruitingNCT05539196

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

Enrollment

60 participants

Start Date

Jan 23, 2023

Study Type

OBSERVATIONAL

Conditions

Movement Disorders Parkinsons Disease Neurology

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

Min Age: 30 YearsMax Age: 99 Years

Inclusion Criteria4

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 Criteria1

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

Interventions

DEVICEExablate Pallidotomy, Unilateral

Unilateral pallidotomy using focused ultrasound for the treatment of Parkinson's Disease with medication-refractory moderate to severe motor complications.