Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy

NCT06965452 | Recruiting FDA Device

• 1 other identifier: 23-1020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Procedure-Related Serious Adverse Events in the Perioperative Period

  The primary outcome measurements for safety are: -The number of procedure-related serious adverse events occurring in the perioperative period

  1 year

Secondary Outcomes (2)

• Proportion of Patients with >20% Improvement in Facetogenic Pain Based on Visual Analog Scale (VAS). Percent from 0% to 100% and higher % represents greater improvement.

  1 year

• Proportion of Patients with >20% Improvement in Disability Based on Oswestry Low Back Pain Disability Questionnaire

  1 year

Study Arms (1)

Embozene Microspheres for Facetogenic Low Back Pain

EXPERIMENTAL

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.

Device: Spinal angiography and embolization/ Embozene Microspheres

Interventions

Spinal angiography and embolization/ Embozene Microspheres DEVICE

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.

Embozene Microspheres for Facetogenic Low Back Pain

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

MeSH Terms

Conditions

Pain; Osteoarthritis; Low Back Pain; Back Pain

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Central Study Contacts

Betsy Moclair

CONTACT

516-253-7753; bmoclair@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention consists of a trans-arterial injection of the vascular supply the facet joints using Embozene microspheres. After patients have failed conservative management with proven facetogenic pain they will be enrolled into the study. Patients will be brought to the neurointerventional suite and have a diagnostic spinal angiogram under procedural sedation. The dorsal segmental arteries supplying the facet joints causing back pain will be embolized using Embozene microspheres approved particles.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 11, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (1)