Elbow Artery Embolization for Tennis Elbow

NCT ID: NCT05325242

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2027-01-01

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).

Detailed 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.

Conditions

Lateral Epicondylitis, Unspecified Elbow

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Embozene particles

Intervention Type: DEVICE

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.

Interventions

Embozene particles

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siddharth Padia, MD

OTHER

Sponsor Role: lead

Responsible Party

Siddharth Padia, MD

Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Siddharth Padia, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aniket Joglekar

Role: CONTACT

AJoglekar@mednet.ucla.edu

310-948-8026

Siddharth A Padia, M.D.

Role: CONTACT

SPadia@mednet.ucla.edu

310-481-7545

Facility Contacts

Aniket Joglekar

Role: primary

AJoglekar@mednet.ucla.edu

310-948-8026

Saima Chaabane, PhD

Role: backup

SChaabane@mednet.ucla.edu

424-465-4482

Other Identifiers

22-000161

Identifier Type: -

Identifier Source: org_study_id