Status:
UNKNOWN
Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain
Lead Sponsor:
FUSMobile Inc.
Collaborating Sponsors:
Sheba Medical Center
Conditions:
Sacroiliitis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis
Detailed Description
Pilot, Interventional, Prospective, Open label, Single Arm study to evaluate Non-invasive thermal ablation of the posterior sacral nerve branches as a treatment of painful sacroiliac joint (SIJ) using...
Eligibility Criteria
Inclusion
- 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
- 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.
- Patient with extensive scarring in the skin and tissue overlying the treatment area.
- Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
Key Trial Info
Start Date :
October 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05396495
Start Date
October 24 2022
End Date
December 1 2024
Last Update
September 7 2023
Active Locations (1)
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1
Sheba Medical Center
Giv‘atayim, Israel