An observational study in Lumbar Zygapophyseal Pain, Low Back Pain and Facet Joint Pain; Low Back Pain, sponsored by FUSMobile Inc.. Not yet recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by FUSMobile Inc. · Observational
The Neurolyser XR demonstrated positive outcomes in the clinical studies prior to obtaining CE marking, and well as in multiple pilot trials performed globally. This Post-Market Clinical Follow-up study is required to evaluate the safety and effectiveness of the Neurolyser XR under real-world conditions.
This is a prospective, multi-center study to support the intended use of the Neurolyser XR from treatment of chronic low back pain. Following the study procedure, all participants will be followed through their 12 Month visit to evaluate safety and effectiveness. The study will be conducted in the European Union in up to 15 different physical locations, utilizing physician investigators who have purchased a Neurolyser XR system and have completed the Neurolsyer XR Training Program.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 481 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →FUSMobile Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients treated with the Neurolyser XR in a commercial setting will be invited to participate in this post-market study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving treatment with the Neurolyser XR
Device: High Intensity Focused Ultrasound
Use of high intensity focused ultrasound (HIFU), or ultrasound energy, to ablate the intended anatomical target.
Also known as: lumbar zygapophyseal pain, nerve ablation
Effectiveness Endpoint - Assessed by change in Numeric Rating Scale (NRS)
Numeric Rating Scale (NRS) is a 10-point scale (0 to 10) with 0=no pain to 10=worst pain
Time frame: Up to 12 Months post procedure
Effectiveness Endpoint - Assessed by change in Patient's Global Impression of Pain (PGIC)
Patient's Global Impression of Pain (PGIC) is a 7-point scale; range from "very much improved" to "very much worse"
Time frame: Up to 12 Months post procedure
Effectiveness Endpoint - X-ray Dose
Analysis of X-ray dose used during the procedure
Time frame: Estimated procedure time is 20 to 60 minutes based on the number of locations treated.
Effectiveness Endpoint - Procedure Time
Analysis of time needed to complete the procedure.
Time frame: Estimated procedure time is 20 to 60 minutes based on the number of locations.
Plan to share: No — The overall study outcomes will be shared, although individual patient data will not be shared at this time.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2029, 37 months later.
Of 185 observational studies under Low Back Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's planned 37 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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FUSMobile Inc.