Trans-arterial Embolization for Facet Joint Arthritis

Overseen By Betsy Moclair

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Pregnancy, Prior spinal embolization, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for individuals experiencing pain from facet arthropathy, which includes osteoarthritis or injury-related joint issues in the spine. Participants should have chronic lower back pain attributed to their facet joints and must have tried standard treatments without success.

Inclusion Criteria

I have pain in up to 2 levels of my lower back.

My lower back pain is confirmed to be from facet joint issues.

I have tried joint injections or nerve destruction treatments without success.

Exclusion Criteria

Modified Rankin Scale >2

Severe allergic reaction to iodinated contrast (i.e. anaphylaxis)

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo trans-arterial embolization using Embozene microparticles for the treatment of facetogenic pain

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Trans-arterial Embolization

Trial Overview The study is testing a procedure called trans-arterial embolization (TAE) using Embozene Microspheres to block blood flow to certain areas of the spine, aiming to reduce pain caused by facet joint arthritis.

How Is the Trial Designed?

Group I: Embozene Microspheres for Facetogenic Low Back Pain Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+