Recruiting

Nexsphere-F vs. SteroidRandomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain

Sponsor:

North American Science Associates Ltd.

Code:

NCT06872567

Conditions

Knee Osteoarthritis (Knee OA)

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

genicular artery embolization

Corticosteroid Injection

Study Details

Brief summary:

Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection

Conditions

Knee Osteoarthritis (Knee OA)

Study ID

NCT06872567

Start date

Oct 1, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patient has localized knee pain
Must be an appropriate candidate for arterial vascular access procedure

Exclusion Criteria:

Known sensitivity or allergy to implant materials
Unable or unwilling to comply with study requirements

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

experimental: Device: GAE

Interventions

genicular artery embolization

Corticosteroid Injection

Primary outcome measure

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 6 and 12-month post treatment ]
Serious Adverse Events (SAE) [ Time Frame: Treatment, 1,3,6,9 and 12-month post treatment ]

Central Contacts and Locations

Central contacts

Ziv J Haskal, MD

16463691570 haskalembo@gmail.com

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

More Information

Sponsor

North American Science Associates Ltd.

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North American Science Associates Ltd. on 2025-11-24.