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High Intensity Focused Ultrasound Device
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial 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 time frame: base line, procedure day, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
Awards & highlights
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ time frame: base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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