Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05325242
Study type Interventional
Source University of California, Los Angeles
Contact Aniket Joglekar
Phone 310-948-8026
Email AJoglekar@mednet.ucla.edu
Status Recruiting
Phase N/A
Start date March 21, 2023
Completion date January 1, 2027

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05125705 - PRP Versus Saline in Lateral Epicondylitis Phase 2/Phase 3
Recruiting NCT05771701 - Pain Pressure Threshold Algometry in Lateral Epicondylitis: Intra- and Inter-rater Reliability N/A
Active, not recruiting NCT04686799 - Doxycycline for Elbow Tendinopathy Phase 1