A Post-Approval Registry for Exablate 4000 Type 1.0 & Type 1.1 for

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05539196
Study type	Observational [Patient Registry]
Source	InSightec
Contact	Nadir Alikacem
Phone	+12146302000
Email	nadira@insightec.com
Status	Recruiting
Phase
Start date	January 23, 2023
Completion date	July 31, 2029

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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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms