Last reviewed · How we verify
NCT04129034
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
NA trial testing Neurolyser XR in Facet Syndrome of Lumbar Spine in 30 participants. Status unknown.
26 October 2022
Quick facts
| Lead sponsor | FUSMobile Inc. |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 24 September 2019 |
| Primary completion | 26 October 2022 |
| Estimated completion | 26 March 2023 |
| Sites | 5 locations across Canada |
Drugs / interventions tested
- Neurolyser XR
Conditions studied
- Facet Syndrome of Lumbar Spine — all drugs for Facet Syndrome of Lumbar Spine →
Sponsor
FUSMobile Inc.
Who can join
Adults 55 to 85, any sex, with Facet Syndrome of Lumbar Spine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Fluoroscopy-guided high-intensity focused ultrasound neurotomy of the lumbar zygapophyseal joints: a prospective, open-label study.
Gofeld M, Smith KJ, Bhatia A, Djuric V, et al · · 2025 · cited 7× · PMID 38580339 · DOI 10.1136/rapm-2024-105345
Verify or expand the search:
- PubMed search for NCT04129034
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Facet Syndrome of Lumbar Spine
Currently open trials in the same condition.
- NCT04893720 — The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration · recruiting
Other FUSMobile Inc. trials
Trials by the same sponsor.
- NCT06053255 — Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis · NA · recruiting
- NCT05396495 — Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain · NA · unknown
- NCT05154448 — Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain · NA · completed
- NCT04519541 — RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain · NA · completed
- NCT05122611 — Post Lumbar Radiofrequency Neurotomy Imaging · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04129034 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by FUSMobile Inc.
- Last refreshed: 1 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04129034.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing