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Non-Invasive Thermal Ablation

Non-Invasive Thermal Ablation of the Medial Branch Nerves (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 base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
Awards & highlights

Study Summary

This trial will test a new, non-invasive treatment for chronic low back pain. The Neurolyser XR will be evaluated for its ability to relieve pain and improve function.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
NRS
Procedure and Device Safety up to six months post procedure
Secondary outcome measures
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographic locations is this clinical trial being conducted?

"Nine facilities are currently taking part in this trial, including Mayo University Jacksonville (Jacksonville), The Physicians Spine and Rehabilitation Specialist of GA (Atlanta) ,and Center for Clinical Research (Winston-Salem). Additionally, there are 6 other sites that have joined the endeavour."

Answered by AI

Does the research encompass participants that are seventieth birthday or older?

"The parameters for participation in this trial are that patients must be between 50 and 85 years old. There is an abundance of trials targeting younger individuals (387) while there are 1248 dedicated to older people."

Answered by AI

How many participants have joined this experiment?

"90 eligible patients are necessary to successfully complete the study. The sponsor, FUSMobile Inc., will be running this trial from various sites; such as Mayo University Jacksonville in Florida and The Physicians Spine and Rehabilitation Specialist of GA in North carolina."

Answered by AI

What prerequisites must be satisfied in order to join this clinical experiment?

"Candidates aged between 50 and 85 afflicted with chronic back pain are eligible to apply for this medical trial. Of note, they must be among the 90 people selected by the research team."

Answered by AI

Does this research endeavor have any vacancies for participants?

"Affirmative. According to the details on clinicaltrials.gov, this medical trial is presently seeking volunteers and was first posted on May 16th 2022 with a subsequent update occurring on July 28th 2022. A total of 90 patients are needed across 9 sites for successful completion."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Georgia
How old are they?
18 - 65
What site did they apply to?
Center for Clinical Research
Emory
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have been dealing with lower back pain for over 20 years. Over time the frequency and severity of the pain has gotten worse. Some days the pain is so intense it keeps me from going to work and some days I can barely stand on my own. I am not interested in any type of surgery and chiropractic treatments have been a very temporary solution at best.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How frequent are the trial visits and how long do they last?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain
2022. "Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05154448.
~30 spots leftby May 2025
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