NCT01699477|UnknownPhase 1DMC
Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain
FUS-CLT
MR-Guided Functional Ultrasound-Neurosurgery
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Sponsor study identifier
interventional
30
1 country
1
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of this study is to asses the efficacy and the clinical safety of the transcranial magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec Ltd. for functional neurosurgery. The treatments to be conducted in this study are non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will be used to evaluate the basic safety aspects of this new treatment technology and will serve as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 27, 2012
Actual (reported)October 3, 2012
Actual (reported)December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Precision of lesioning
Comparison of size and location of sonicaion lesions on MRI with planning coordinates.
3 months
Safety measurements
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
6 months
Lesion characteristics
Size of lesions as a function of applied energy/temperature.
3 months
Clinical Efficacy
1 year
Non-invasive brain intervention using MR-guided focused ultrasound
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
MR-Center, University Children's Hospital
Zurich, Canton of Zurich, CH-8032, Switzerland
Ernst - Martin, MD
University Children's Hospital, Zurich
Ronald - Bauer, MD
Neurosurgery, Kantonsspital St. Gallen, Switzerland
Gunther - Landmann, MD
Center for Pain Medicine, Nottwil, Switzerland
First Submitted
April 27, 2012
First Posted
October 3, 2012
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 3, 2012
Record last verified: 2012-10
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Source: ClinicalTrials.gov.
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