The primary purpose of this protocol is to assess the ExAblate 2100 MR guided high intensity focused ultrasound device as an intervention for treatment of facetogenic lower back pain.
This is a single group, single arm, open/nonblinded, non-randomized study. The primary outcomes are safety and preliminary efficacy. The InSightec ExAblate 2100 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.The study will reach primary completion 12 months from the time the study opens to accrual.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The InSightec ExAblate 2100 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.
Stanford University
Stanford, California, United States
Device Related Complications as a Measure of Safety
Safety will be determined by evaluating for the incidence and severity of any device related complication from the treatment day visit through 24 months after treatment.
Time frame: 24 months
Pain Relief on the Visual Analog Scale
Effectiveness will be determined by the level of pain relief, as measured by the NRS, and decrease in analgesic/opiate use.
Time frame: 24 months
Quality of Life Improvement
Effectiveness will be determined by improved quality of life, as measured by the Oswestry Disability Index.
Time frame: 24 months
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