OsteoarthritisNCT07537153
Genicular Artery Embolization for Knee Osteoarthritis
A study testing Embosphere Microspheres in people with Osteoarthritis and Knee Osteoarthritis, run by Northwestern University at 1 site in United States.
Trial summary
Patients will be asked to take part in this research study because they have mild-to-moderate knee osteoarthritis (OA) and were referred clinically for a procedure called Genicular Artery Embolization (GAE). Osteoarthritis is the most common form of arthritis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- Embosphere Microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2026to 10 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Robert Lewandowski, MD, 312-695-9121, r-lewandowski@northwestern.edu
About this study
Official title: Genicular Artery Embolization for Patients With Mild-To-Moderate Knee Osteoarthritis
Patients will be asked to take part in this research study because they have mild-to-moderate knee osteoarthritis (OA) and were referred clinically for a procedure called Genicular Artery Embolization (GAE). Osteoarthritis is the most common form of arthritis. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. The symptoms of OA include pain or aching, stiffness, decreased range of motion, and swelling. The purpose of this study is to evaluate the safety and effectiveness of GAE for the treatment of knee pain attributed to OA.
Research participants will be in this research study for about 3 years. The study includes a screening visit, GAE procedure, and six follow-up visits.
Read more
At the screening visit, a review of their medical history, demographics, and medications will be collected; physical examination will be completed; knee x-ray will be done; and two questionnaires on your knee pain will be administered. The GAE procedure will involve receiving sedation or medication to help them relax, lidocaine injected under the skin in the area of the body where catheters will be inserted into one of your arteries and then using x-ray, a catheter will be directed to the arteries supplying the lining of the knee. Then tiny microspheres will be injected into the artery to decrease the blood supply to this knee joint tissue.
The follow-up visits up to 12 months will include a focused physical examination of the treated knee, documentation of medications, and two questionnaires will be administered. The follow-up visits at year 2 and 3 will include documentation of medications and any new treatments for OA as well as completion of two questionnaires. Follow-up visits maybe conducted in clinic or remotely.
- Conditions
- Osteoarthritis, Knee Osteoarthritis
- Being tested
- Embosphere Microspheres
- Keywords
- Osteoarthritis, Knee Osteoarthritis, Genicular Artery Embolization, GAE, Embosphere Microspheres, GAE Knee, GAE Embosphere Microspheres
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embosphere MicrospheresDevice
Genicular Artery Embolization is performed by either inserting a small catheter into the artery of the upper thigh or an artery at the wrist, and with the use of x-ray, the catheter is guided to the arteries supplying the lining of the knee. Tiny particles are then injected through the catheter into these arteries, reducing the blood supply. These small particles are considered a medical device called Embosphere Microspheres. These microspheres are approved by the Food and Drug Administration (FDA) in the United States to treat hypervascular tumors; in the prostate arteries to relieve symptoms related to benign prostate hyperplasia; and to address arteriovenous malformations. The use of Embosphere Microspheres in this study is considered experimental as it has not been approved by the FDA to reduce pain associated with knee OA.
| Study group | Role | What they receive |
|---|---|---|
| GAE Procedure | Experimental | All participants will undergo a procedure called Genicular Artery Embolization (GAE) that will be done to try to reduce the pain in their knees. Receives: Device: Embosphere Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient safety endpoints
Primary safety endpoints include:
- Incidence and severity of adverse events (AEs). These include:
- Non-target embolization (e.g., distal leg)
- All transient intra- and post-procedure events (e.g., skin changes)
- Death
Measured: Screening/baseline, 1, 3, and 6 months
Objective clinical endpoints - Cone beam computed tomography
Change in enhancement on cone beam computed tomography (CT)
Measured: Immediately pre-and post-embolization
Objective clinical endpoints - VAS
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
Measured: Screening/baseline, 1, 3, 6, 12, 24 and 36 months
Objective clinical endpoints - WOMAC
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).
Measured: Screening/baseline, 1, 3, 6, 12, 24 and 36 months
Secondary outcomes (2)
Preliminary Effectiveness - WOMAC
Secondary endpoint will be evaluated based on existing validated pain scoring systems. The 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 will be utilized. Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).
Measured: Screening/baseline, 1, 3, 6, and 12 months
Preliminary Effectiveness - VAS
Secondary endpoint will be evaluated based on existing validated pain scoring systems. The 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) will be utilized. Consequently, higher scores indicate a worse outcome (more pain/severity), while lower scores indicate a better outcome.
Measured: Screening/baseline, 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start10 Jul 2026
- Primary completion10 Apr 2028 (estimated)
- Study completion10 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Responsible party
- Principal investigator, Robert Lewandowski, Northwestern University
- Investigators
- Robert Lewandowski, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537153
- Sponsor's protocol ID
- STU00223591
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genicular Artery Embolization for Patients With Mild-To-Moderate Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07537153
- Acronym / sponsor ID
- STU00223591
- Conditions
- Osteoarthritis, Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee Osteoarthritis, Genicular Artery Embolization, GAE, Embosphere Microspheres, GAE Knee, GAE Embosphere Microspheres
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 10 Apr 2028 (estimated)
- Study completion
- 10 Apr 2031 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will be asked to take part in this research study because they have mild-to-moderate knee osteoarthritis (OA) and were referred clinically for a procedure called Genicular Artery Embolization (GAE). Osteoarthritis is the most common form of arthritis. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. The symptoms of OA include pain or aching, stiffness, decreased range of motion, and swelling. The purpose of this study is to evaluate the safety and effectiveness of GAE for the treatment of knee pain attributed to OA.
Research participants will be in this research study for about 3 years. The study includes a screening visit, GAE procedure, and six follow-up visits.
At the screening visit, a review of their medical history, demographics, and medications will be collected; physical examination will be completed; knee x-ray will be done; and two questionnaires on your knee pain will be administered. The GAE procedure will involve receiving sedation or medication to help them relax, lidocaine injected under the skin in the area of the body where catheters will be inserted into one of your arteries and then using x-ray, a catheter will be directed to the arteries supplying the lining of the knee. Then tiny microspheres will be injected into the artery to decrease the blood supply to this knee joint tissue.
The follow-up visits up to 12 months will include a focused physical examination of the treated knee, documentation of medications, and two questionnaires will be administered. The follow-up visits at year 2 and 3 will include documentation of medications and any new treatments for OA as well as completion of two questionnaires. Follow-up visits maybe conducted in clinic or remotely.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GAE Procedure | Experimental | Device: Embosphere MicrospheresAll participants will undergo a procedure called Genicular Artery Embolization (GAE) that will be done to try to reduce the pain in their knees. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embosphere MicrospheresGenicular Artery Embolization is performed by either inserting a small catheter into the artery of the upper thigh or an artery at the wrist, and with the use of x-ray, the catheter is guided to the arteries supplying the lining of the knee. Tiny particles are then injected through the catheter into these arteries, reducing the blood supply. These small particles are considered a medical device called Embosphere Microspheres. These microspheres are approved by the Food and Drug Administration (FDA) in the United States to treat hypervascular tumors; in the prostate arteries to relieve symptoms related to benign prostate hyperplasia; and to address arteriovenous malformations. The use of Embosphere Microspheres in this study is considered experimental as it has not been approved by the FDA to reduce pain associated with knee OA. | Device | GAE Procedure |
Primary outcome
Patient safety endpoints
Time frame: Screening/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 tomography
Time frame: Immediately pre-and post-embolization
Change in enhancement on cone beam computed tomography (CT)
Objective clinical endpoints - VAS
Time frame: Screening/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 - WOMAC
Time frame: Screening/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).
2 secondary outcomes
Preliminary Effectiveness - WOMAC
Time frame: Screening/baseline, 1, 3, 6, and 12 months
Preliminary Effectiveness - VAS
Time frame: Screening/baseline, 1, 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Lewandowski, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embosphere Microspheres in people with Osteoarthritis and Knee Osteoarthritis, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Lewandowski, MD (312-695-9121, r-lewandowki@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient safety endpoints (time frame: Screening/baseline, 1, 3, and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.