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Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain

Sacroiliitis Clinical Trial

Official title:
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain

Clinical Trial Summary

Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05396495
Study type Interventional
Source FUSMobile Inc.
Contact Glia Pesah
Phone +972 52 3213525
Email Galia.Pesah@sheba.health.gov.il
Status Recruiting
Phase N/A
Start date October 24, 2022
Completion date December 1, 2024
View Details
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