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

NCT05154448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-02-07

No results posted yet for this study

Summary

Double arm pivotal study to evaluate the Neurolyser XR as a 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 (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

Sponsors & Collaborators

  • FUSMobile Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2024-04-16
Completion
2024-04-16
FDA Device
Yes

Countries

  • United States

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 NCT05154448 on ClinicalTrials.gov