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

NCT04519541 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-09-07

No results posted yet for this study

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

Conditions

  • Facet Syndrome of Lumbar Spine

Interventions

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

Sponsors & Collaborators

  • Rambam

    collaborator UNKNOWN

  • FUSMobile Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2022-09-11
Completion
2023-01-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04519541 on ClinicalTrials.gov