UnknownNot Applicable

Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain

Israel10 participantsStarted 2022-10-24

Plain-language summary

Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis

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 male 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 younger than 18 or older than 80 years
. 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

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

Effectiveness per pain score using numerical rating scale of 0 to 10

Timeframe: Baseline throughout the follow-up period of six months

Safety per adverse events

Timeframe: Baseline throughout the follow-up period of six months

Trial details

NCT IDNCT05396495

SponsorFUSMobile Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-01

Contact for this trial

Glia Pesah

+972 52 3213525 Galia.Pesah@sheba.health.gov.il

View on ClinicalTrials.gov More Sacroiliitis trials