MR-Guided Focused Ultrasound in the Treatment of Focal Epilepsy (EP001)
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ClinicalTrials.gov Identifier: NCT02804230 |
Recruitment Status :
Recruiting
First Posted : June 17, 2016
Last Update Posted : November 1, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | June 14, 2016 | ||||
First Posted Date ICMJE | June 17, 2016 | ||||
Last Update Posted Date | November 1, 2021 | ||||
Study Start Date ICMJE | June 2016 | ||||
Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Incidence and severity of device and procedure related complications [ Time Frame: At the time of ExAblate Transcranial procedure ] | ||||
Original Primary Outcome Measures ICMJE |
Severity of device and procedure related complications [ Time Frame: At the time of ExAblate Transcranial procedure ] | ||||
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 | MR-Guided Focused Ultrasound in the Treatment of Focal Epilepsy | ||||
Official Title ICMJE | A Feasibility Study to Evaluate Safety and Initial Effectiveness of MR-Guided Focused Ultrasound Ablation Therapy in the Treatment of Focal Epilepsy | ||||
Brief Summary | The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of Exablate thermal ablation of a focal epileptic target area in the brain of patients suffering from medication-refractory epilepsy, using the Exablate transcranial system to produce multiple sonications targeted in the focus of interest. The investigators will establish the feasibility and collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. | ||||
Detailed Description | The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of Exablate thermal ablation of a focal epileptic target area in the brain of patients suffering from medication-refractory epilepsy, using the Exablate transcranial system to produce multiple sonications targeted in the lesion of interest. The Investigators will establish the feasibility and collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The hypotheses tested are that:
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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: Treatment |
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Condition ICMJE | Epilepsy, Unspecified, Refractory (Medically) | ||||
Intervention ICMJE | Device: MRgFUS Ablation of Epileptic Foci
MR-Guided Focused Ultrasound
Other Names:
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Study Arms ICMJE | Experimental: MRgFUS Ablation of Epileptic Foci
MR-Guided Focused Ultrasound
Intervention: Device: MRgFUS Ablation of Epileptic Foci
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE |
10 | ||||
Estimated Study Completion Date ICMJE | June 2024 | ||||
Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02804230 | ||||
Other Study ID Numbers ICMJE | EP001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | InSightec | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | InSightec | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | InSightec | ||||
Verification Date | October 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |