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NCT01304758 · ClinicalTrials.gov registry record · Phase 1
ExAblate Transcranial MR Guided Focused Ultrasound in the Treatment of Essential Tremor
A Phase 1 study, sponsored by InSightec.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01304758 is a Phase 1 study that has completed, run by InSightec. The registered enrollment target is 15 participants.
The verdict
NCT01304758, a Phase 1 study, has completed, sponsored by InSightec.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from medication-refractory Essential Tremor, using the ExAblate transcranial system. The ExAblate system is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study the targeted tissue is a unilateral thermal lesion created in the ventralis intermedius nucleus of the thalamus. The treatment begins with a series of standard diagnostic MR images to identify the location and shape of tumor to be treated. The ExAblate computer uses the physician's designation of the target volume to plan the best way to cover the target volume with small spots called "sonications". These treatment spots are cylinder shaped. Their size depends on sonication power and duration. During the treatment, a specific MR scan, which can be processed to identify changes in tissue temperature, provides a thermal map of the treatment volume to confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress, and confirm that the ablation is proceeding according to plan, thus closing the therapy loop. The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing 1000-element phased array transducer) positioned above the subject head. The ExAblate transcranial system also includes means to immobilize the subject head, cool the interface water, and software for CT analysis and phase correction computation. The ExAblate transcranial system is an experimental device and is being investigated in this study.
Interventions
- DEVICE ExAblate Transcranial MRgFUS System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01304758
The ClinicalTrials.gov registry entry for NCT01304758 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InSightec, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ExAblate Transcranial MRgFUS System is the first listed.
NCT01304758 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01304758 about?
NCT01304758 is a clinical study titled "ExAblate Transcranial MR Guided Focused Ultrasound in the Treatment of Essential Tremor". The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from medication-refractory Essential Tremor, using the ExAblate transcranial system. The ExAblate system is a medic...
What is the current status of trial NCT01304758?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2011-01. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01304758?
The interventions under investigation include: ExAblate Transcranial MRgFUS System (DEVICE).
Who is sponsoring clinical trial NCT01304758?
This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.
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