Open Actively Recruiting

Elbow Artery Embolization for Tennis Elbow

About

Brief 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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
80 Years

Inclusion 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.

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

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Share:
Study Stats
Protocol No.
22-000161
Category
Healthy Volunteers
Contact
Christian Barrera
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05325242
For detailed technical eligibility, visit ClinicalTrials.gov.