Status:
RECRUITING
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Lead Sponsor:
Northwell Health
Conditions:
Facet Joint Arthropathy
Pain
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This single-site, single-arm study evaluates the feasibility, safety, tolerability, and efficacy of trans-arterial embolization (TAE) using Embozene microparticles for treating facetogenic pain due to...
Detailed Description
This is a single site, single-arm study assessing the feasibility, safety, tolerability, and efficacy of trans-arterial embolization for the treatment of facet pain due to facet arthropathy. Osteoarth...
Eligibility Criteria
Inclusion
- Age 18-85
- Confirmed diagnosis of spinal facet arthropathy on MRI OR CT
- Confirmed diagnosis of lumbosacral facetogenic pain based on diagnostic nerve blocks.
- Failed medical management of pain.
- Back pain persistent for at least 6 months
- Pain worse than at least 6/10 on a visual analog pain scale
- Failed at least one of either intra-articular injections of steroids/ anesthetics or neuro-ablative procedure.
- Maximum of 2 spinal levels of facetogenic pain in the lumbar and sacral spine (i.e. L4-5 and L5-S1).
- Modified Rankin Scale 0-2
Exclusion
- \- Pregnancy
- History of prior spinal embolization at the target level.
- History of surgery/ stenting of the aorta at the level of embolization.
- Severe allergic reaction to iodinated contrast (i.e. anaphylaxis)
- Creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 mL/min (except if patients is already on hemodialysis).
- Modified Rankin Scale \>2
- Angiographic/ Procedural Exclusion Criterion: Vascular supply to the spinal cord from the vessels supplying the facet joints targeted for embolization.
Key Trial Info
Start Date :
August 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06965452
Start Date
August 12 2025
End Date
August 1 2026
Last Update
August 19 2025
Active Locations (1)
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1
North Shore University Hospital
Manhasset, New York, United States, 11030