RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Trans Arterial Embolization for Facet Arthropathy

Quick Facts

Study Start:2025-08-12
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06965452

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-85
  2. * Confirmed diagnosis of spinal facet arthropathy on MRI OR CT
  3. * Confirmed diagnosis of lumbosacral facetogenic pain based on diagnostic nerve blocks.
  4. * Failed medical management of pain.
  5. * Back pain persistent for at least 6 months
  6. * Pain worse than at least 6/10 on a visual analog pain scale
  7. * Failed at least one of either intra-articular injections of steroids/ anesthetics or neuro-ablative procedure.
  8. * Maximum of 2 spinal levels of facetogenic pain in the lumbar and sacral spine (i.e. L4-5 and L5-S1).
  9. * Modified Rankin Scale 0-2
  1. * - Pregnancy
  2. * History of prior spinal embolization at the target level.
  3. * History of surgery/ stenting of the aorta at the level of embolization.
  4. * Severe allergic reaction to iodinated contrast (i.e. anaphylaxis)
  5. * Creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 mL/min (except if patients is already on hemodialysis).
  6. * Modified Rankin Scale \>2
  7. * Angiographic/ Procedural Exclusion Criterion: Vascular supply to the spinal cord from the vessels supplying the facet joints targeted for embolization.

Contacts and Locations

Study Contact

Betsy Moclair
CONTACT
516-253-7753
bmoclair@northwell.edu

Study Locations (Sites)

North Shore University Hospital
Manhasset, New York, 11030
United States

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-12
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2025-08-12
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Facet Joint Arthropathy
  • Pain
  • Osteoarthritis