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Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor (ET004)

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ClinicalTrials.gov Identifier: NCT03935581
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief Summary:
The objective of this study is to evaluate the safety and feasibility of Auto Focusing (AF) echo imaging using the ExAblate Neuro system

Condition or disease Intervention/treatment Phase
Tremor, Essential Neurologic Manifestations Tremor Device: ExAblate Not Applicable

Detailed Description:
This clinical investigation is a feasibility study designed to evaluate the safety and feasibility of the ExAblate Neuro system to perform AF echo imaging in patients diagnosed with idiopathic Essential Tremor. during the standard care procedure for ET, patients will be injected with Definity microbubbles which will enable the ExAblate Neuro system to perform the AF imaging.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Assessment of Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Idiopathic Essential Tremor With Medication Refractory Tremor
Actual Study Start Date : April 25, 2019
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ExAblate 4000 System
ExAblate Neuro system to perform AF echo imaging in treatment of Essential Tremor
Device: ExAblate
Auto Focusing (AF) echo imaging




Primary Outcome Measures :
  1. Incidence of Device and Procedure related Adverse Events [ Time Frame: Treatment through 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female age 22 years or older
  2. Able and willing to give consent and able to attend all study visits
  3. A confirmed diagnosis of Essential Tremor resistant to medication therapy
  4. Able to fit into MRI unit
  5. Able to tolerate the procedure with or without some form of sedation
  6. Able to communicate sensations during the ExAblate MRgFUS procedure
  7. Able to activate Stop Sonication button during the ExAblate MRgFUS procedure

Exclusion Criteria:

  1. Presence of unknown or MRI unsafe devices anywhere in the body.
  2. Patients with known intolerance or allergies to the MRI contrast agents
  3. Women who are pregnant
  4. Patients with advanced kidney disease or on dialysis
  5. Significant cardiac disease or unstable hemodynamic status
  6. Patients exhibiting any behavior(s) consistent with ethanol or substance abuse
  7. History of a bleeding disorder
  8. Patients receiving anticoagulant or drugs known to increase risk of hemorrhage
  9. Patients with cerebrovascular disease
  10. Patients with brain tumors
  11. Individuals who are not able or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)
  12. Patients who are currently participating in another clinical investigation
  13. Patients unable to communicate with the investigator and staff
  14. Patients who have cardiac shunts
  15. Patients with relative contraindications to Definity ultrasound contrast agent including subjects with a family or personal history of arrhythmia's
  16. Patients with chronic pulmonary disorders
  17. Patients with a history of drug allergies, uncontrolled asthma or hay fever
  18. Patients who have had deep brain stimulation or a prior neuroablative procedure
  19. Women who are pregnant or nursing
  20. Patients who have been administered botulinum toxins into the arm, neck, or face for 5 months prior to enrollment in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935581


Contacts
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Contact: Khaja Rehman 469-607-0497 khajar@insightec.com
Contact: Brian Ostrander 469 607 0482 briano@Insightec.com

Locations
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Canada, Ontario
Sunnybrook Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Korea, Republic of
Yonsei University Health System, Severance Hospital Recruiting
Seoul, Seodaemun-gu, Korea, Republic of, 03722
Contact: Eunjung Kweon    02-2227-4578    kweonej@yuhs.ac   
Principal Investigator: Jin Woo Chang, MD         
Sponsors and Collaborators
InSightec
Investigators
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Principal Investigator: Nir Lipsman Sunnybrook Health Science Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03935581    
Other Study ID Numbers: ET004
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by InSightec:
MRgFUS
ExAblate
Essential Tremor
Auto-Focusing Echo Imaging
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Neurologic Manifestations
Dyskinesias
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases