RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Spinal angiography and embolization/ Embozene Microspheres for Facet Joint Arthropathy

This single-site, single-arm study evaluates the feasibility, safety, tolerability, and how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT06965452 · Northwell Health · enrollment listed as 40

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Spinal angiography and embolization/ Embozene Microspheres. The registry lists allocation as na. This single-site, single-arm study evaluates the feasibility, safety, tolerability, and how well it works 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.

They plan to enroll about 40 people at Manhasset. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Trans Arterial Embolization for Facet Arthropathy

Interventions: Spinal angiography and embolization/ Embozene Microspheres

Primary outcome (registry wording): Number of Procedure-Related Serious Adverse Events in the Perioperative Period

Who it is for (from inclusion criteria)

Ages 18 Years to 85 Years
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)

Who the registry excludes

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

Public study contact (from the registry)

Betsy Moclair

516-253-7753

bmoclair@northwell.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

North Shore University Hospital — Manhasset, New York (recruiting)

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FAQ about this NCT record

Is NCT06965452 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06965452?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06965452?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary