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Non-Invasive Thermal Ablation

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

N/A
Waitlist Available
Research Sponsored by FUSMobile Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure

Summary

This trial tests the Neurolyser XR, a non-invasive device, on adults with chronic low back pain from small joint issues in the spine. It aims to relieve pain by targeting nerves or tissues without surgery.

Eligible Conditions
  • Lumbar Facet Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: base line, 1, & 4 weeks, 3 & 6 months after procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: base line, 1, & 4 weeks, 3 & 6 months after procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
NRS
Procedure and Device Safety up to six months post procedure
Secondary study objectives
Oswestry Disability Index (ODI)
Patient Global Impression of Change (PGIC)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Thermal ablation of the medial nerve branch using High Intensity Focused UltrasoundExperimental Treatment1 Intervention
Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR High Intensity Focused Ultrasound device
Group II: Sham treatmentPlacebo Group1 Intervention
The procedure would be done in an identical manner to the NeurolyserXR treatment without any person in the procedure room knowing that this is a sham procedure. The only difference is that the acoustic energy would not be output from the system during a sham procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)
2022
N/A
~90

Who is running the clinical trial?

FUSMobile Inc.Lead Sponsor
6 Previous Clinical Trials
80 Total Patients Enrolled
~25 spots leftby Dec 2025
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