Recruiting

TAE with Embozene

Sponsor:

Northwell Health

Code:

NCT06965452

Conditions

Facet Joint Arthropathy

Pain

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spinal angiography and embolization/ Embozene Microspheres

Study Details

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

Conditions

Facet Joint Arthropathy

Pain

Osteoarthritis

Study ID

NCT06965452

Start date

Aug 12, 2025

Status verified date

Aug, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Embozene Microspheres for Facetogenic Low Back Pain

This is a single site, single arm study to assess the safety and efficacy of trans arterial embolization using Embozene microspheres of the facet joint for the treatment of facetogenic low back pain.

Interventions

Spinal angiography and embolization/ Embozene Microspheres

Once consent is obtained the patient will be scheduled for spinal angiography and embolization. The patient will undergo the procedure at North Shore University Hospital. After embolization the patient will be monitored in recovery for 5 hours and then discharged to home.

The primary objective of this study is to examine the safety and feasibility of trans arterial embolization of the facet joint using Embozene Microspheres for the treatment of back pain from facet arthropathy and osteoarthritis.

Primary outcome measure

  • Number of Procedure-Related Serious Adverse Events in the Perioperative Period [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Betsy Moclair

516-253-7753bmoclair@northwell.edu

Locations

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Betsy Moclair

516-253-7753bmoclair@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Facetogenic pain
  • Facet pain
  • Facet joint pain
  • Low back pain
  • Back Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-09-01.