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



Status:Recruiting
Conditions:Parkinsons Disease, Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:11/22/2018
Start Date:December 2016
End Date:January 2024
Contact:Project Manager
Phone:1-214-630-2000

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

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.

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.

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
We found this trial at
6
sites
Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Howard Eisenberg, MD
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Jeff Elias, MD
Phone: 434-243-1435
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Gordon Baltuch, MD, PhD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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Seattle, Washington 98122
Principal Investigator: Ryder Gwinn, MD
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Seattle, WA
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Pejman Ghanouni, MD
Phone: 650-498-0817
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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Toronto, Ontario
Principal Investigator: Michael Schwartz, MD
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Toronto,
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