Elbow Artery Embolization for Tennis Elbow

Description

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).

Conditions

Lateral Epicondylitis, Unspecified Elbow

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Study Overview

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Study Details

Study overview

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).

Safety and Efficacy of Elbow Artery Embolization (EAE) for the Treatment of Lateral Epicondylitis

Elbow Artery Embolization for Tennis Elbow

Condition
Lateral Epicondylitis, Unspecified Elbow
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years and less than 80 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.
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Siddharth Padia, MD,

Siddharth Padia, M.D., PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

2027-01-01