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

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InSightec

Status

Active, not recruiting

Conditions

Essential Tremor
Neuropathic Pain
Movement Disorders
Parkinson's Disease

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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