Elbow Artery Embolization for Tennis Elbow
Safety and Efficacy of Elbow Artery Embolization (EAE) for the Treatment of Lateral Epicondylitis
Siddharth Padia, MD
25 participants
Mar 21, 2023
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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
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Interventions
Embozene particles are FDA approved for the embolization of hypervascular tumors and arteriovenous malformations. Several studies have shown excellent safety and efficacy with regards to tumor control and objective response in liver cancer. It has been used extensively for the treatment of symptomatic uterine fibroids, where Embozene embolization of the uterine arteries results in necrosis of uterine fibroids and cessation of abnormal vaginal bleeding. Other proven uses include embolization of arteriovenous malformations and fistulas.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05325242