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出境医 / 临床实验 / Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor (ET004)

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

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 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.
Study Design
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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
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
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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.
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date March 18, 2021
Actual Study Start Date  ICMJE April 25, 2019
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019) 		Incidence of Device and Procedure related Adverse Events [ Time Frame: Treatment through 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Tremor, Essential
  • Neurologic Manifestations
  • Tremor
Intervention  ICMJE Device: ExAblate
Auto Focusing (AF) echo imaging
Study Arms  ICMJE Experimental: ExAblate 4000 System
ExAblate Neuro system to perform AF echo imaging in treatment of Essential Tremor
Intervention: Device: ExAblate
Publications *
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Khaja Rehman 469-607-0497 khajar@insightec.com
Contact: Brian Ostrander 469 607 0482 briano@Insightec.com
Listed Location Countries  ICMJE Canada,   Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935581
Other Study ID Numbers  ICMJE ET004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nir Lipsman Sunnybrook Health Science Centre
PRS Account InSightec
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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