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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

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

Clinicaltrials.gov identifier NCT03935581

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted April 29, 2020

Study Description

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:Tremor
    Tremor, Essential
    Neurologic Manifestations
  • Intervention/Treatment: Device: ExAblate
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • 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 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: January 2021
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 1. Incidence of Device and Procedure related Adverse Events [ Time Frame: Treatment through 1 month ]
Eligibility Criteria
  • Ages Eligible for Study: 22 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.

Contacts and Locations
Contacts

Contact: Khaja Rehman 469-607-0497 khajar@insightec.com

Contact: Brian Ostrander 469 607 0482 briano@Insightec.com

Locations

Canada, Ontario
Sunnybrook
Toronto

Korea, Republic of, Seodaemun-gu
Yonsei University Health System, Severance Hospital
Seoul

Sponsors and Collaborators

InSightec

Investigators

Principal Investigator: Nir Lipsman Sunnybrook Health Science Centre

More Information
  • Responsible Party: InSightec
  • ClinicalTrials.gov Identifier: NCT03935581 History of Changes
  • Other Study ID Numbers: ET004
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: April 29, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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.: Yes
  • Keywords provided by InSightec: MRgFUS
    ExAblate
    Essential Tremor
    Auto-Focusing Echo Imaging
  • Additional relevant MeSH terms: Tremor
    Essential Tremor
    Neurologic Manifestations