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RECRUITING
NCT05539196

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

30 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2023-01-23

Completion Date

2029-07-31

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DEVICE

Exablate Pallidotomy, Unilateral

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

Locations (5)

University of Maryland, Baltimore

Baltimore, Maryland, United States

Weill Cornell Medicine

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Ohnishi Neurological Center

Akashi, Hyōgo, Japan