Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Recruiting at 4 trial locations
MG
Overseen ByMichael Gofeld, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: FUSMobile Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving active treatment for rheumatologic diseases with steroids, disease-modifying drugs, biological agents, or immunosuppressants, you may not be eligible to participate.
What safety data exists for Neurolyser XR or similar treatments?
How is the drug Neurolyser XR different from other treatments for this condition?
Are You a Good Fit for This Trial?
Inclusion Criteria
Patients presenting with a) a positive (>70% pain relief) to a previous, single or double, L1 to L5 lumbar medial branch block (within the last 12 months) and / or b) with a positive (>70% pain relief lasting more than 6 months) to a previous lumbar facet thermal radiofrequency denervation.
You have been experiencing pain in your low back for more than 6 months on either one or both sides.
Your back pain is relieved when you lie down or sit in a comfortable position.
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Exclusion Criteria
You are pregnant or currently breastfeeding.
Patients with known osteoporosis with absolute risk of spinal fracture of >10% over 10 years will be excluded
Patients known for concomitant psychiatric disorders, excluding mood disorders.
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound
Procedure day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Visits at baseline, 2 days, 1, 2 & 4 weeks, 3 & 6 months
What Are the Treatments Tested in This Trial?
Interventions
- Neurolyser XR
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound
Find a Clinic Near You
Who Is Running the Clinical Trial?
FUSMobile Inc.
Lead Sponsor
Trials
7
Recruited
170+
Published Research Related to This Trial
A study analyzing 3,940 cases from the FDA Adverse Event Reporting System found that taxane-related neurotoxicity, particularly peripheral neuropathy, is common, especially among elderly patients and females.
The median time for neurological adverse effects to appear after taxane treatment was 27 days, with a significant portion of cases occurring within the first 30 days, and the study reported a fatality rate of 6.13% and hospitalization rate of 28.63% for these adverse events.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Neurotoxicity induced by taxane-derived drugs: analysis of the FAERS database 2017-2021.Zhang, J., Luo, L., Long, E., et al.[2023]
The study presents a curated and standardized version of the FDA Adverse Event Reporting System (FAERS) data, which enhances the quality and usability of drug safety surveillance by removing duplicates and standardizing drug and outcome vocabularies.
This new resource will facilitate faster and more reliable drug safety research by providing pre-computed statistics and reducing the time needed for data management, ultimately improving the identification of adverse drug reactions (ADRs) post-marketing.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A curated and standardized adverse drug event resource to accelerate drug safety research.Banda, JM., Evans, L., Vanguri, RS., et al.[2020]
The study found that there is no formal definition of 'adversity' or guidance on determining the No Observed Adverse Effect Level (NOAEL) in safety pharmacology, indicating a lack of standardized practices in this area.
It was concluded that using NOAEL in safety pharmacology is not recommended, as the diverse functional endpoints measured do not fit into a simple toxic/non-toxic classification, suggesting a need for more nuanced risk assessments in drug development.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Is there a role for the no observed adverse effect level in safety pharmacology?Mow, T., Andersen, NK., Dragsted, N., et al.[2021]
Citations
Neurotoxicity induced by taxane-derived drugs: analysis of the FAERS database 2017-2021. [2023]
A curated and standardized adverse drug event resource to accelerate drug safety research. [2020]
Is there a role for the no observed adverse effect level in safety pharmacology? [2021]
[Adverse drug events in out-patients as the cause of an initial consultation to neurology]. [2013]
Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011. [2021]
From Synthetic Fragments of Endogenous Three-Finger Proteins to Potential Drugs. [2020]
Synthesis, Activity, and Application of Fluorescent Analogs of [D1G, Δ14Q]LvIC Targeting α6β4 Nicotinic Acetylcholine Receptor. [2023]
Pharmacotherapeutic implications of the association between genomic instability at chromosome 15q13.3 and autism spectrum disorders. [2013]
An insecticide target in mechanoreceptor neurons. [2023]
Alexa Fluor 546-ArIB[V11L;V16A] is a potent ligand for selectively labeling alpha 7 nicotinic acetylcholine receptors. [2021]
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