Last updated: September 6, 2023
Sponsor: FUSMobile Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Ankylosing Spondylitis
Treatment
NeurolyserXR
Clinical Study ID
NCT05396495
SIJ-001
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult male and females, legally able and willing to participate in the study and comefor follow-up visits
- Able and willing to fill the research questionnaires and to communicate withinvestigator 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 ablationprocedure of the sacroiliac joint and / or b) with a positive (>70% pain relief) to aprevious 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
Exclusion Criteria:
- Pregnant or breastfeeding patient
- Patients younger than 18 or older than 80 years
- Patients presenting with neurological deficits (including lumbosacral radiculopathybut 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 / orinfluence symptoms and / or generate unrelated adverse event (per the discretion ofthe study PI)
- Patients unable to understand and complete the research questionnaires in Hebrew.
- Patients presenting with any severe medical condition preventing the patient fromsafely 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 theduration of this research project
Study Design
Total Participants: 10
Treatment Group(s): 1
Primary Treatment: NeurolyserXR
Phase:
Study Start date:
October 24, 2022
Estimated Completion Date:
December 01, 2024
Study Description
Connect with a study center
Sheba Medical Center
Givatayim,
IsraelActive - Recruiting
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