Osteoarthritis study: Embosphere Microspheres
Official title Genicular Artery Embolization for Knee Osteoarthritis
ClinicalTrials.gov ID: NCT07537153
What this study is testing
- What it's testing
- The study wants to see if GAE is safe and can help reduce knee pain caused by osteoarthritis.
- Who it's for
- It is looking for adults who have mild or moderate knee osteoarthritis and have been referred for the GAE procedure.
- What's involved
- Participants will have a screening visit, then receive the GAE procedure under sedation. Afterward they will attend up to six follow‑up visits where doctors examine the knee, review medications, and complete pain questionnaires. Some visits may be done in the clinic or remotely.
- Time commitment
- The study lasts about three years, with a screening visit, the procedure, and follow‑up visits at 1, 3, 6, 9, 12 months, and at years 2 and 3.
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Age 40-80 years
- Mild-to-moderate knee OA as determined by radiographs demonstrating Kellgren- Lawrence grade 2-3
- Self-reported pain of at least 5/10 VAS questionnaire
- Failure of conservative therapy, such as pain medications, for at least 3 months
- Patient must understand and sign the informed consent
You likely can't join if
- History of rheumatoid arthritis
- Renal insufficiency precluding angiography (GFR \< 50 mL/min)
- Irreversible coagulopathy
- Previous knee arthroplasty on the intended knee
- Existing knee joint infection
- Kellgren-Lawrence grade 1 or 4
See the full eligibility criteria
- Age 40-80 years
- Mild-to-moderate knee OA as determined by radiographs demonstrating Kellgren- Lawrence grade 2-3
- Self-reported pain of at least 5/10 VAS questionnaire
- Failure of conservative therapy, such as pain medications, for at least 3 months
- Patient must understand and sign the informed consent
- Patient can comply with the proposed follow-up schedule
- Patient can follow the post-operative management
- History of rheumatoid arthritis
- Renal insufficiency precluding angiography (GFR \< 50 mL/min)
- Irreversible coagulopathy
- Previous knee arthroplasty on the intended knee
- Existing knee joint infection
- Kellgren-Lawrence grade 1 or 4
- Severe atherosclerosis as manifest by claudication and/or diminished peripheral pulses
- Life expectancy \< 6 months
- Infectious arthritis
- Allergy to iodinated contrast resulting in anaphylaxis
- Pregnant or interested in becoming pregnant three months from the date of the GAE procedure
- Involved in litigation or worker's compensation claims
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.