Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy (NCT06965452) | Clinical Trial Compass
RecruitingNot Applicable
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
United States40 participantsStarted 2025-08-12
Plain-language 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 facet arthropathy (osteoarthritis of the facet joints) in the lumbar spine.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Procedure-Related Serious Adverse Events in the Perioperative Period