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A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor

NCT03253991 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2023-04-20

No results posted yet for this study

Summary

A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

The objective of this prospective, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor inpatients with essential tremor (ET).

The Indications for Use claim for this system is as follows: Treatment of medication-refractory tremor in patients with essential tremor.

Conditions

Interventions

DEVICE

MRgFUS treatment

ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-17
Primary Completion
2023-02-02
Completion
2023-02-02

Countries

  • China
  • Japan
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03253991 on ClinicalTrials.gov