Trans Arterial Embolization for Facet Arthropathy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
North Shore University Hospital
RECRUITING
Manhasset
Contact Information
Primary
Betsy Moclair
bmoclair@northwell.edu
516-253-7753
Time Frame
Start Date: 2025-08-12
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov