NCT06965452 · Northwell Health
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
What this study is about
This single-site, single-treatment group$1 study evaluates the feasibility, safety, tolerability, and effectiveness 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Where
- Manhasset, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2025 · Source of record for eligibility and locations