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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

NCT05539196 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-03-20

No results posted yet for this 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.

Conditions

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.

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Eligibility

Min Age
30 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2029-07-31
Completion
2029-07-31
FDA Device
Yes

Countries

  • United States
  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05539196 on ClinicalTrials.gov