Elbow Artery Embolization for Tennis Elbow

Siddharth Padia, MD

Status: Enrolling

Conditions: Lateral Epicondylitis, Unspecified Elbow

Treatments: Device: Embozene particles

Study type: Interventional

Funder types: Other

Identifiers

NCT05325242

22-000161

Details and patient eligibility

About

The purpose of this clinical research study is to examine whether embolization treatment of an elbow artery is a safe and effective way to treat elbow pain, specifically pain from tennis elbow. Embozene is a medical device made by Varian marketed in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery to block the flow of blood to a specific region. One of the causes of pain in the setting of tennis elbow is increased blood flow going to the specific area of pain. In this study, we will investigate an experimental procedure to decrease the blood flow (embolize) to the specific region of the elbow that is causing the pain. This will be done by infusing Embozene particles into the specific blood vessel supplying the area of pain in the elbow. This is an investigational study to evaluate the safety and efficacy of elbow artery embolization (EAE) for the treatment of symptomatic lateral epicondylitis (tennis elbow).

Full description

This is a single-center, prospective, single arm investigational study to evaluate the safety of elbow artery embolization (EAE) for treatment of symptomatic lateral epicondylitis. In addition, the improvement as part of efficacy will be reported. All patients will have either failed or be intolerant to conservative management. Patients will be considered enrolled in the study once they have provided informed consent and have been determined to meet all eligibility criteria. A total of 25 patients will be enrolled in the single treatment arm of the study and will be followed for 24 months.

The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, subjects will undergo EAE with Embozene microspheres (75 micron). Following treatment, subjects will return for follow-up visits at 1 week, 1 month (± 2 weeks), 3 months (± 2 weeks), 6 months (± 4 weeks), 12 months (± 4 weeks), and 24 months (± 4 weeks) post-procedure. At these visits, subjects will undergo a directed physical examination, report any new adverse events (AEs), and complete questionnaires. At 12 months of follow-up, subjects will also undergo elbow MRI and x-ray.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Diagnosis of lateral epicondylitis based on history and physical exam
• Ability to provide informed consent
• Life expectancy greater than 12 months
• Moderate-severe lateral elbow pain as determined by visual analog scale > 4 (based on average severity during physical activity)
• Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection) for at least 6 months.

Exclusion criteria

• Mild elbow pain as determined by visual analog scale < 4
• Chronic renal insufficiency (serum creatinine >2 mg/dL)
• Allergy to iodinated contrast agents that is not responsive to steroid management
• Active Infection or malignancy
• Prior elbow surgery in the subject elbow
• Uncorrectable bleeding diathesis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Elbow Artery Embolization (EAE)

Experimental group

Description:

Patients will undergo EAE with Embozene microspheres (75 micron). The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the patient's pain.

Treatment:

Device: Embozene particles