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

Age range18 Years – 80 Years

SexALL

See this in plain English?

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

✓. 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).

✕. 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
✕. 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)
✕. Patients unable to understand and complete the research questionnaires in Hebrew.
✕. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.

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

NCT IDNCT05396495

SponsorFUSMobile Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-01

Glia Pesah

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

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

✓. 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).

✕. 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
✕. 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)
✕. Patients unable to understand and complete the research questionnaires in Hebrew.
✕. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.