Recruiting

Genicular Artery Embolization

Sponsor:

Northwestern University

Code:

NCT07537153

Conditions

Osteoarthritis

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Embosphere Microspheres

Study Details

Brief 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. 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.

Conditions

Osteoarthritis

Knee Osteoarthritis

Study ID

NCT07537153

Start date

Jul 10, 2026

Status verified date

Jul, 2026

Completion date

Apr 10, 2031

Anticipated

Primary completion date

Apr 10, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GAE Procedure

All participants will undergo a procedure called Genicular Artery Embolization (GAE) that will be done to try to reduce the pain in their knees.

Interventions

Embosphere Microspheres

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.

Primary outcome measure

  • Patient safety endpoints [ Time Frame: Screening/baseline, 1, 3, and 6 months ]
  • Objective clinical endpoints - Cone beam computed tomography [ Time Frame: Immediately pre-and post-embolization ]
  • Objective clinical endpoints - VAS [ Time Frame: Screening/baseline, 1, 3, 6, 12, 24 and 36 months ]
  • Objective clinical endpoints - WOMAC [ Time Frame: Screening/baseline, 1, 3, 6, 12, 24 and 36 months ]

Central Contacts and Locations

Central contacts

Robert Lewandowski, MD

312-695-9121r-lewandowki@northwestern.edu

Kristie Kennedy, MA

312-695-4023kristie.kennedy@northwestern.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Robert Lewandowski, MD

312-695-9121r-lewandowski@northwestern.edu

More Information

Sponsor

Northwestern University

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Osteoarthritis
  • Knee Osteoarthritis
  • Genicular Artery Embolization
  • GAE
  • Embosphere Microspheres
  • GAE Knee
  • GAE Embosphere Microspheres

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-07-14.