NCT04379700

Geniculate Artery Embolization for Treatment of Osteoarthritis

Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the feasibility and safety of transcatheter arterial embolization in patients with mild to moderate radiographic knee OA. Eligible participants will receive geniculate artery embolization using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 12 months.

Detailed description

The current study seeks to determine whether transcatheter arterial embolization of abnormal neovasculature arising from the genicular arterial branches is safe and effective in the treatment of mild-to-moderate knee OA.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Transcatheter arterial embolization	Transcatheter arterial embolization of one or more genicular artery(ies) using Embozene™ Color-Advanced Microspheres. Embozene™ Color-Advanced Microspheres are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer used for embolization.
DEVICE	Embozene™ Microspheres	Embozene™ Microspheres are spherical, tightly calibrated, biocompatible, nonresorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer (Polyzene™-F). The microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue. They are available in prefilled syringes in a range of sizes suitable for embolic therapy. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter and color-coded by size to allow for easy identification. 250 μm microsphere will be used and are supplied in prefilled yellow syringes.

Timeline

• Start date: 2020-12-01
• Primary completion: 2025-03-12
• Completion: 2025-03-12
• First posted: 2020-05-07
• Last updated: 2025-06-18
• Results posted: 2025-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study