Genicular Artery Embolization for Knee Osteoarthritis
This study is looking at a procedure called Genicular Artery Embolization (GAE) using Embosphere Microspheres to treat knee pain caused by mild-to-moderate osteoarthritis (OA). OA happens when the protective cartilage in your knee wears down. GAE involves guiding a small tube (catheter) to the arteries in your knee to help with pain. The study wants to see if GAE is safe and effective. You may be able to join if you are 40-80 years old, have mild-to-moderate knee OA, experience at least 5/10 pain, and haven't found relief with other treatments for at least 3 months. The study will measure your safety and pain levels over time.
- Study design
- This is an interventional study with a planned enrollment of 15 participants. The study does not specify if it is randomized or blinded.
- What's involved
- You would be in this study for about 3 years, including a screening visit, the GAE procedure, and six follow-up visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be checked at 1, 3, and 6 months. Your pain levels will be checked at 1, 3, 6, 12, 24, and 36 months after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Genicular Artery Embolization for Knee Osteoarthritis
At a glance
Conditions
NCT07537153
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Northwestern University
Chicago, Illinoisstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Robert Lewandowski, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
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Inclusion
Exclusion
What this trial measures
- Patient safety endpointsScreening/baseline, 1, 3, and 6 months
Primary safety endpoints include: 1\. Incidence and severity of adverse events (AEs). These include: 1. Non-target embolization (e.g., distal leg) 2. All transient intra- and post-procedure events (e.g., skin changes) 3. Death
- Objective clinical endpoints - Cone beam computed tomographyImmediately pre-and post-embolization
Change in enhancement on cone beam computed tomography (CT)
- Objective clinical endpoints - VASScreening/baseline, 1, 3, 6, 12, 24 and 36 months
Change in Visual Analogue Scale (VAS), a measurement instrument where 0 represents the minimum value (e.g., no pain) and 100 (or 10) represents the maximum value (e.g., worst imaginable pain). Consequently, higher scores indicate a worse outcome (more pain/severity), while lower scores indicate a better outcome
- Objective clinical endpoints - WOMACScreening/baseline, 1, 3, 6, 12, 24 and 36 months
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a measurement instrument designed to evaluate pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).