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

NCT ID: NCT03100474

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Essential Tremor Parkinson's Disease Movement Disorders Neuropathic Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InSightec

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Eisenberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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Stanford University

Stanford, California, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Swedish Neuroscience Institute

Seattle, Washington, United States

Site Status

Sunnybrook

Toronto, Ontario, Canada

Site Status

Rambam Healthcare Campus

Haifa, , Israel

Site Status

Sheba Medical Center

Ramat Gan, , Israel

Site Status

Chang Bing Show Chwan Memorial Hospital

Chang-hua, , Taiwan

Site Status

Countries

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United States Canada Israel Taiwan

Other Identifiers

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ND001

Identifier Type: -

Identifier Source: org_study_id

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