Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain
Public ClinicalTrials.gov record NCT05154448. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
High-Intensity Focused Ultrasound Ablation With the Neurolyser XR Device for the Treatment of Chronic Low Back Pain: a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study
Study identification
- NCT ID
- NCT05154448
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- FUSMobile Inc.
- Industry
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Interventions
- Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR) Device
- Sham procedure Other
Device · Other
Eligibility (public fields only)
- Age range
- 50 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 15, 2022
- Primary completion
- Apr 15, 2024
- Completion
- Apr 15, 2024
- Last update posted
- Feb 6, 2025
2022 – 2024
United States locations
- U.S. sites
- 10
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stamford Hospital | Stamford | Connecticut | 06902 | — |
| Mayo University Jacksonville | Jacksonville | Florida | 32224 | — |
| Univ of Miami Rehabilitation Medicine | Miami | Florida | 33136 | — |
| Emory | Atlanta | Georgia | 30322 | — |
| The Physicians Spine and Rehabilitation Specialist of GA | Atlanta | Georgia | 30328 | — |
| Charlie Norwood VA Medical Center | Augusta | Georgia | 30904 | — |
| Ainsworth Institute of Pain Management | New York | New York | 10022 | — |
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| University of Virginia Pain Management Center | Charlottesville | Virginia | 22904 | — |
| Gershon Pain Specialists | Virginia Beach | Virginia | 23454 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05154448, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 6, 2025 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05154448 live on ClinicalTrials.gov.