NCT05396495

Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: FUSMobile Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Sacroiliitis

Interventions

Type	Name	Description
DEVICE	NeurolyserXR	Using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint

Timeline

• Start date: 2022-10-24
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-05-31
• Last updated: 2023-09-07

Locations

1 site across 1 country: Israel