NCT03321344

Safety and Initial Feasibility of Using the Neurolyser for Facet Related Low Back Pain

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

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

Summary

Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a new portable high intensity focused ultrasound device, for noninvasive thermal ablation of medial nerve branches of painful lumbar facet joint/s

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 McGill University. Study population: Ten adult patients diagnosed with facet related low back pain. Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of facet related low back pain. Safety would be evaluated by the incidence and severity of treatment related adverse events Efficacy would be evaluated by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 months.

Conditions

• Facet Related Low Back Pain

Interventions

Type	Name	Description
DEVICE	Focused Ultrasound Thermal ablation	Focused Ultrasound Thermal ablation of the Medial Nerve Branch

Timeline

• Start date: 2017-12-05
• Primary completion: 2019-02-28
• Completion: 2020-02-19
• First posted: 2017-10-25
• Last updated: 2021-01-25

Locations

1 site across 1 country: Canada