Neurolyser XR for the Treatment of Sacroiliitis (NCT07647757) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neurolyser XR for the Treatment of Sacroiliitis
Italy30 participantsStarted 2026-07
Plain-language summary
Our study aims to investigate the safety and efficacy of high intensity focused ultrasound in the management of low back pain due to sacroiliitis. Sacroiliitis is the inflammation of a joint in the lowest part of the spin and it is one of the cause of low back; the diagnosis is essentially based on clinical examination and the confirmation of this diagnosis relies on a significant pain relief following an infiltration of local anesthetic in the joint. One of the potential treatment is to ablate the nerves which carry the painful stimuli from the joint to the central nervous system through; these nerves enter the spinal canal through the sacral foramina which are two series of four pairs of openings located on the sacrum, the triangular bone at the base of the spine. Traditionally, these nerves are ablated by the heat produced by radiofrequency or the cold produced by cryoablation; both techniques require percutaneous needle insertion in close proximity to the targeted nerves, posing potential discomfort and risk of infection for the patient. High intensity focused ultrasound delivered by the device Neurolyser XR uses ultrasounds which are converged to the targeted point thanks to a gel pad positioned on the back of the patient; this mechanism of action does not require sterile conditions as the skin is not pierced and the discomfort of patient is dramatically reduced during the procedure for there is non need to insert and move any needle to properly position it. The correct orientation of the ultrasound beam is guaranteed by the alignment of the targeting system of the device and the X-ray image. The lesion is produced only if there is a bone right under the focus of the ultrasound beam and this is a safety system which assures that no direct injuries of other structures (e.g., vessels, spinal root) can be caused. To date, Neurolyser XR has been extensively used to treat facet joint syndrome through the ablation of the medial branches. However, its application in sacroiliitis has not yet been as deeply investigated.
Who can participate
Age range
18 Years – 80 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:
* Adult males and females, legally able and willing to participate in the study and come for follow-up visits
* Able and willing to fill the research questionnaires and to communicate with investigator and research team
* Patient with bilateral or unilateral sacroiliac joint pain of \> 6 months duration
* Patients presenting with a) a positive (\>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (\>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)
* Average pain score of 4 or higher in the last month, (on 0-10 scale).
Exclusion Criteria:
* Pregnant or breastfeeding patient
* Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
* Patients with history of lumbar and / or sacral spine surgery
* Patients with the presence of metal hardware at the lumbosacral spine
* Patients with history of pelvic pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event (per the discretion of the study principal investigator)
* Patients unable to understand and complete the research questionnaires in Italian.
* Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
* Patient with extensive scarring in the skin and tissue overlying the treat…
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.
1Since this trial is listed as 'not yet recruiting,' how soon do you think it might open, and should I start another treatment now rather than waiting to see if I'm a candidate?
2The trial is testing the Neurolyser XR device for sacroiliitis — can you explain what this device actually does to treat sacroiliac joint pain, and how it differs from other procedures you'd consider for my case?
3The trial is listed as Phase NA, which can mean it's studying a device rather than a drug — does that change what we know about its safety profile, and what risks should I be aware of before considering it?
4Since the main thing this trial is measuring is pain intensity, what would count as a meaningful improvement in pain for me personally, and how would we track whether any treatment — this device or something else — is actually working?
5Are there established treatments for sacroiliitis, like injections, physical therapy, or other interventional options, that you'd recommend I try first while this trial is still in the pre-recruitment stage?
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
1
Pain intensity
Timeframe: From the enrollment to the end of 6 month follow-up