Study Designed to Assess the Efficacy and Safety of the Neurolyser XR After Marketing Approval
Lumbar Zygapophyseal Pain · Low Back Pain · Facet Joint Pain; Low Back Pain
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- Not specified - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 60 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
1. Diagnosis of lumbar zygapophyseal pain and eligible for treatment with the Neurolyser XR according to standard clinical practice.
2. Ability to understand the study requirements and provide informed consent.
Exclusion Criteria:
1. Participation in another interventional clinical study that may interfere with the outcomes of this study.
2. Pregnancy or breastfeeding.
Study population
All patients treated with the Neurolyser XR in a commercial setting will be invited to participate in this post-market study.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
Neurolyser XR
Participants receiving treatment with the Neurolyser XR
Device: High Intensity Focused Ultrasound
High Intensity Focused Ultrasound DEVICE
Use of high intensity focused ultrasound (HIFU), or ultrasound energy, to ablate the intended anatomical target.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Effectiveness Endpoint - Assessed by change in Numeric Rating Scale (NRS)
Time frame: Up to 12 Months post procedure
Numeric Rating Scale (NRS) is a 10-point scale (0 to 10) with 0=no pain to 10=worst pain
Effectiveness Endpoint - Assessed by change in Patient's Global Impression of Pain (PGIC)
Time frame: Up to 12 Months post procedure
Patient's Global Impression of Pain (PGIC) is a 7-point scale; range from "very much improved" to "very much worse"
Secondary measures
Effectiveness Endpoint - X-ray Dose
Time frame: Estimated procedure time is 20 to 60 minutes based on the number of locations treated.
Analysis of X-ray dose used during the procedure
Effectiveness Endpoint - Procedure Time
Time frame: Estimated procedure time is 20 to 60 minutes based on the number of locations.
Analysis of time needed to complete the procedure.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Klinik PmAlicante, SpainStatus unknown
Study team and timeline
- Lead sponsor
- FUSMobile Inc.
- Study start
- Nov 12, 2026 Estimated
- Primary completion
- Dec 31, 2029 Estimated
- Study completion
- Dec 31, 2029 Estimated
- First posted
- Nov 9, 2026 Actual
- Last updated
- Nov 9, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Prospective, Multicenter, International, Post-Market, Observational Study to Assess the Efficacy and Safety of Neurolyser XR
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026