Actively Recruiting
Resorbable Embolization MicroSpheres for Osteoarthritis Benefit
Led by North American Science Associates Ltd. · Updated on 2025-11-24
126
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
N
North American Science Associates Ltd.
Lead Sponsor
N
Next Biomedical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research is a multi-center, prospective, randomized trial comparing genicular artery embolization (GAE) using Nexsphere-F with intra-articular corticosteroid injection for patients experiencing knee osteoarthritis pain. The study aims to evaluate and compare these two treatments in managing localized knee pain associated with osteoarthritis. The trial is sponsored by North American Science Associates Ltd. and does not involve blinding of participants or researchers. Participants will be randomly assigned to one of two groups: one receiving genicular artery embolization, a device-based procedure, and the other receiving corticosteroid injections directly into the knee joint. These interventions are being assessed to understand their impact on knee osteoarthritis symptoms. The treatment phase and follow-up include multiple assessments over a one-year period. During the study, participants will undergo evaluations using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6, 9, and 12 months post-treatment to measure pain, stiffness, and physical function. Researchers will also monitor serious adverse events at treatment and follow-up visits to ensure safety. The total participation duration includes treatment and up to 12 months of post-treatment monitoring for outcomes and safety.
CONDITIONS
Brief Title
Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has localized knee pain
- Must be an appropriate candidate for arterial vascular access procedure
- Age 40 years or older
You will not qualify if you...
- Known sensitivity or allergy to implant materials
- Unable or unwilling to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months with crossover treatment
Participants receive either genicular artery embolization or a corticosteroid knee injection as part of the study treatments.
Multiple visits for treatment and assessments over 12 months
Duration - Up to 12 months post treatment
Participants are monitored for treatment outcomes and safety through scheduled assessments after receiving the treatments.
Visits at 1, 3, 6, 9, and 12 months post treatment
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
Z
Ziv J Haskal, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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