NCT04519541

RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain

Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: FUSMobile Inc. · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain

Detailed description

Study design: Prospective, single arm Timeline: six month enrollment period and 12 months follow-up period. Sites: The study will be conducted at five sites in Canada: McGill University, Toronto Western, Silver Medical Group, Precision Sport \& Spine, Kinetix Integrated Orthopaedic \& Regenerative Medicine Study population: Thirty adult patients diagnosed with facet related low back pain. Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome. Safety is measured by the incidence and severity of treatment related adverse events. Efficacy is measured by the changes in pain severity at the treatment area, using a numerical rating scale (NRS), of 0 to 10 between baseline and 6 months.

Conditions

• Facet Syndrome of Lumbar Spine

Interventions

Type	Name	Description
DEVICE	Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR	Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

Timeline

• Start date: 2021-02-03
• Primary completion: 2022-09-11
• Completion: 2023-01-31
• First posted: 2020-08-19
• Last updated: 2023-09-07

Locations

1 site across 1 country: Israel