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High Intensity Focused Ultrasound Device

Neurolyser XR for Lumbar Facet Syndrome

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 time frame: base line, procedure day, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
Awards & highlights

Summary

This trial is testing the Neurolyser XR, a device that uses strong sound waves to treat chronic low back pain in adults. It targets painful spine joints without surgery. The study aims to see if this method is safe and effective.

Eligible Conditions
  • Lumbar Facet Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: base line, 2 days 1, 2 & 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
Therapeutic procedure
Secondary study objectives
Lesion Size
Oswestry Disability Index (ODI)
Patient Global Impression of Change (PGIC)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

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Who is running the clinical trial?

FUSMobile Inc.Lead Sponsor
6 Previous Clinical Trials
140 Total Patients Enrolled
~5 spots leftby Sep 2025
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