Elbow Artery Embolization for Tennis Elbow
Safety and Efficacy of Elbow Artery Embolization (EAE) for the Treatment of Lateral Epicondylitis
1 other identifier
interventional
25
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2022
CompletedFirst Posted
Study publicly available on registry
April 13, 2022
CompletedStudy Start
First participant enrolled
March 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 23, 2026
March 1, 2026
4.8 years
February 17, 2022
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the efficacy of EAE in treating pain measured as percentage of subjects with a greater than 50% decrease in QuickDASH (Disabilities of the Arm, Shoulder, and Hand) score at 12 months.
Changes in QuickDASH (Disabilities of the Arm, Shoulder, and Hand) score as a measure of efficacy.
12 months
Secondary Outcomes (4)
Changes in Visual Analog Scan (VAS) as a measure of efficacy
24 months
Change in symptoms as assessed by the QuickDASH scores.
24 months
Change in symptoms as assessed by the patient-rates tennis elbow evaluation (PRTEE) scores.
24 months
Change in imaging
12 months
Study Arms (1)
Elbow Artery Embolization (EAE)
EXPERIMENTALPatients 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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Los Angeles
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siddharth Padia, M.D.
University of California, Los Angeles
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Radiology
Study Record Dates
First Submitted
February 17, 2022
First Posted
April 13, 2022
Study Start
March 21, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 23, 2026
Record last verified: 2026-03