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NCT05154448
Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain
NA trial testing Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR) in Facet Syndrome of Lumbar Spine in 90 participants. Completed in 16 April 2024.
16 April 2024
Quick facts
| Lead sponsor | FUSMobile Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 16 May 2022 |
| Primary completion | 16 April 2024 |
| Estimated completion | 16 April 2024 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)
- Sham procedure — full drug profile →
Conditions studied
- Facet Syndrome of Lumbar Spine — all drugs for Facet Syndrome of Lumbar Spine →
Sponsor
FUSMobile Inc.
Who can join
Adults 50 to 85, any sex, with Facet Syndrome of Lumbar Spine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05154448
- 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
- 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
- NCT04129034 — Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain · NA · unknown
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 NCT05154448 (US National Library of Medicine, public domain)
- 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: 7 February 2025
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/NCT05154448.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing