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Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis
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Pilot, Interventional, Prospective, Open label, Single Arm study to evaluate Non-invasive thermal ablation of the posterior sacral nerve branches as a treatment of painful sacroiliac joint (SIJ) using High Intensity Focused Ultrasound delivered by the Neurolyser XR.
Patient would be treated and then followed for up to 6 months. Primary safety endpoint will be measured by the incidence and severity of treatment related adverse events Primary effectiveness endpoint will be measured by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 and 12 months
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10 participants in 1 patient group
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Central trial contact
Glia Pesah
Data sourced from clinicaltrials.gov
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