Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint 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

Interventional

Phase

Not applicable

Age range

18 years - 80 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

10 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

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. Adult male and females, legally able and willing to participate in the study and come for follow-up visits
2. Able and willing to fill the research questionnaires and to communicate with investigator and research team
3. Patient with bilateral or unilateral sacroiliac joint pain of \> 6 months duration
4. 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)
5. Average pain score of 4 or higher in the last month, (on 0-10 scale).

Exclusion Criteria:

1. Pregnant or breastfeeding patient
2. Patients younger than 18 or older than 80 years
3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
4. Patients with history of lumbar and / or sacral spine surgery
5. Patients with the presence of metal hardware at the lumbosacral spine
6. 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 PI)
7. Patients unable to understand and complete the research questionnaires in Hebrew.
8. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
9. Patient with extensive scarring in the skin and tissue overlying the treatment area.
10. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project

Treatment, 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 applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

FUSMobile Inc.

Study start

Sep 24, 2024 Actual

Primary completion

May 1, 2027 Estimated

Study completion

Jul 1, 2027 Estimated

First posted

May 31, 2022 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.