NCT05154448

Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain

High-Intensity Focused Ultrasound Ablation With the Neurolyser XR Device for the Treatment of Chronic Low Back Pain: a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: FUSMobile Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain

Detailed description

Study design: Prospective, Double Arm Timeline: Twelve months enrollment period and 6 months follow-up period. Sites: The study will be conducted at 10 sites in the USA Study population: 80 adult subjects diagnosed with facet related low back pain with an additional 10 roll in subjects. Arms: 40 patients would be treated by the NeurolyserXR and 40 would get a sham treatment Crossover: blinded crossover between the two arms could be done between 1 and 3 months 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 pain numerical rating scale

Conditions

• Facet Syndrome of Lumbar Spine

Interventions

Type	Name	Description
DEVICE	Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)	Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound
OTHER	Sham procedure	Sham procedure done in an identical manner to the treatment arm, but without deploying acoustical energy

Timeline

• Start date: 2022-05-16
• Primary completion: 2024-04-16
• Completion: 2024-04-16
• First posted: 2021-12-13
• Last updated: 2025-02-07

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study