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Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy

RecruitingNAAges 18 Years - 85 YearsAllNorthwell Health
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In plain words

What the trial is, and whether it could suit you

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 facet arthropathy (osteoarthritis of the facet joints) in the lumbar spine.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * \- 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.
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What it tests

  • Spinal angiography and embolization/ Embozene Microspheres
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Where

1 site
North Shore University Hospital
Manhasset, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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