RecruitingNot Applicable

Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis

United States10 participantsStarted 2024-09-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men and women aged 18 and older
. BPI \< 40
. Patients who are able and willing to give consent and able to attend all study visits.
. Patients who are able to communicate with the treating physician.
. Patients must have chronic lower back pain (LBP) attributed to degenerative sacroiliitis diagnosed by a pain physician using the following guidelines:
. At least 1 positive sacroiliac joint provocation test (Gaeslen's test, FABER (Patrick's test), and pelvic rock)
. Back pain predominantly below L5
. 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).

Exclusion criteria

. Patients on dialysis
. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0.

Timeframe: Procedure through 6 month follow-up visit

Trial details

NCT IDNCT06053255

SponsorFUSMobile Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-15

Contact for this trial

Alexi Moruza

434-243-5676 AM2JT@uvahealth.org

View on ClinicalTrials.gov More Sacroiliitis trials