Recruiting

Neurolyser XR

Sponsor:

FUSMobile Inc.

Code:

NCT06053255

Conditions

Sacroiliitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR

Study Details

Brief summary:

The Neurolyser XR is a device used to deliver high-intensity focused ultrasound for the ablation of the lateral sacral branch nerve in patients with Sacroiliitis.

Conditions

Sacroiliitis

Study ID

NCT06053255

Start date

Sep 13, 2024

Status verified date

May, 2025

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Sep 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Men and women aged 18 and older
2. BPI < 40
3. Patients who are able and willing to give consent and able to attend all study visits.
4. Patients who are able to communicate with the treating physician.
5. Patients must have chronic lower back pain (LBP) attributed to degenerative sacroiliitis diagnosed by a pain physician using the following guidelines:
6. At least 1 positive sacroiliac joint provocation test (Gaeslen's test, FABER (Patrick's test), and pelvic rock)
7. Back pain predominantly below L5
8. 50% relief following either sacroiliac joint (SI) joint injection and/or lateral branch blocks corresponding to the expected duration of the medication utilized. (i.e SI joint injection-expected pain relief duration of steroid, lateral branch blocks-expected pain relief duration of local anesthetic utilized).
9. All other possible sources of low back pain have been ruled out as the primary pain generator, including but not limited to: the intervertebral discs, bone fracture, the zygapophyseal joints, the hip joint, symptomatic spondylolisthesis, tumor, and other regional soft tissue structures (this is done by physical exam, medical history, and MRI/CT/X-ray as required)
10. Patients with NRS (0-10 scale) LBP average score ≥ 4
11. Patients with chronic LBP for at least 12 months.
12. Patients with Oswestry Disability Questionnaire (ODQ) for LBP score > 40%

Exclusion Criteria:

1. Patients on dialysis
2. Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain (symptomatic moderate or severe foraminal or central canal stenosis).
3. Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher.
4. Spondylolisthesis at L5/S1, or scoliosis
5. Patients with radiofrequency ablation (RF/RFA) treatment for sacroiliitis LBP
6. Patients with bilateral sacroiliitis LBP
7. Patients with previous low back surgery
8. Patients who are pregnant
9. Patients with existing malignancy
10. Patients with allergies to relevant anesthetics
11. Patients with motor deficit or any other indication for surgical intervention
12. Patients with contraindications for MRI
13. Patients with an acute medical condition (e.g., pneumonia, sepsis, systemic infection, uncontrolled immunosuppression-AIDS, cancer, DM) that is expected to hinder them from completing this study.
14. Patients with unstable cardiac status including:
15. Unstable angina pectoris on medication
16. Patients with documented myocardial infarction less than 40 days prior to protocol enrolment
17. Patients with Severe Congestive Heart Failure, New York Heart Association (NYHA) class 4.
18. Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status
19. Patients with severe cerebrovascular disease (CVA within last 6 months)
20. Patients with severe hypertension (diastolic BP > 100 on medication)
21. Patient Body Mass Index > 45 or <20
22. Patients with known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
23. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
24. The patient is unable to communicate with the investigator and staff.
25. Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hours)
26. Patient with acute pelvic inflammatory conditions
27. Ongoing/ unresolved Worker's compensation, injury litigation, military medical board, or disability remuneration claims
28. Morphine Milligram Equivalents (MME) > 60 per 24 hrs.
29. Patients with platelets < 100.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HIFU for Sacroiliitis

High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis.

Interventions

High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR

HIFU is delivered via a non-invasive ultrasonic transducer, through a gel pad for acoustic coupling, into the patients body in a precise manner focused on the lateral sacral branch nerves.

Primary outcome measure

  • The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0. [ Time Frame: Procedure through 6 month follow-up visit ]

Central Contacts and Locations

Central contacts

Locations

University of Virginia, Department of Anesthesiology

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Principal Investigator:

Lynn R Kohan, MD

More Information

Sponsor

FUSMobile Inc.

Last update posted

May 22, 2025

Last verified

May, 2025

Keywords

  • neurolysis
  • high-intensity focused ultrasound
  • nerve ablation
  • neurotomy
  • sacral joint pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by FUSMobile Inc. on 2025-05-22.