Safety and Feasibility of ExAblate Neuro System to Perfor... | NCT03935581

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

NCT03935581

Sponsor

InSightec

Status

Unknown status

Last Update Posted

Sep 17, 2021Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Tremor, Essential
Neurologic Manifestations
Tremor

Interventions

ExAblate

Countries

Canada
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Apr 18, 2019

First Submission Date that Met QC Criteria

May 1, 2019

First Posted Date

May 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2021

Last Update Posted Date

Sep 17, 2021Actual

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
ExAblate 4000 System	Experimental	ExAblate Neuro system to perform AF echo imaging in treatment of Essential Tremor	Device: ExAblate

Name	Type	Description	Arm Group Labels	Other Names
ExAblate	Device	Auto Focusing (AF) echo imaging	ExAblate 4000 System

Measure	Description	Time Frame
Incidence of Device and Procedure related Adverse Events		Treatment through 1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Nir Lipsman	Sunnybrook Health Science Centre	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook		Toronto	Ontario	M4N 3M5	Canada
Yonsei University Health System, Severance Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33510610	Derived	Chang KW, Rachmilevitch I, Chang WS, Jung HH, Zadicario E, Prus O, Chang JW. Safety and Efficacy of Magnetic Resonance-Guided Focused Ultrasound Surgery With Autofocusing Echo Imaging. Front Neurosci. 2021 Jan 12;14:592763. doi: 10.3389/fnins.2020.592763. eCollection 2020.
32815611	Derived	Jones RM, Huang Y, Meng Y, Scantlebury N, Schwartz ML, Lipsman N, Hynynen K. Echo-Focusing in Transcranial Focused Ultrasound Thalamotomy for Essential Tremor: A Feasibility Study. Mov Disord. 2020 Dec;35(12):2327-2333. doi: 10.1002/mds.28226. Epub 2020 Aug 20.

ID	Term
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D012816	Signs and Symptoms

ID	Term
D020329	Essential Tremor
D009461	Neurologic Manifestations
D014202	Tremor