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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Aniket Joglekar
AJoglekar@mednet.ucla.edu
310-948-8026
Backup
Siddharth A Padia, M.D.
SPadia@mednet.ucla.edu
310-481-7545
Time Frame
Start Date: 2023-03-21
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 25
Treatments
Experimental: Elbow Artery Embolization (EAE)
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.
Related Therapeutic Areas
Sponsors
Leads: Siddharth Padia, MD

This content was sourced from clinicaltrials.gov