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

Part of paid clinical trials in Manhasset, New York.

Sponsor
Northwell Health
Study ID
NCT06965452
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 12, 2025
Status verified
Aug 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
North Shore University HospitalManhassetNew York11030
Betsy Moclair
516-253-7753

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