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NCT03100474 Clinical Trial

Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:

Parkinson's Disease Clinical Trial

Official title:
Global Registry: ExAblate 4000 Transcranial MR Guided Focused Ultrasound (TcMRgFUS) of Neurological Disorders:

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03100474
Other study ID # ND001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 2016
Est. completion date January 2024

Study information
Verified date April 2023
Source InSightec
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.

Description:

A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date January 2024
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Meets labeling indication for use per information for prescribers - Target is accessible by Focused Ultrasound per treatment planning parameters Exclusion Criteria: - Do not agree to participate or who are unlikely to participate over an extended period of time

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Sunnybrook Toronto Ontario
Israel Rambam Healthcare Campus Haifa
Israel Sheba Medical Center Ramat Gan
Taiwan Chang Bing Show Chwan Memorial Hospital Chang Hua
United States University of Maryland Baltimore Maryland
United States University of Virginia Charlottesville Virginia
United States University of Pennsylvania Philadelphia Pennsylvania
United States Swedish Neuroscience Institute Seattle Washington
United States Stanford University Stanford California

Sponsors (1)
Lead Sponsor Collaborator
InSightec

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Rating Scale for Tremor CRST 5 year
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