RECRUITING

Elbow Artery Embolization for Tennis Elbow

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-03-21
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05325242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years and less than 80 years
  2. * Diagnosis of lateral epicondylitis based on history and physical exam
  3. * Ability to provide informed consent
  4. * Life expectancy greater than 12 months
  5. * Moderate-severe lateral elbow pain as determined by visual analog scale \> 4 (based on average severity during physical activity)
  6. * Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection) for at least 6 months.
  1. * Mild elbow pain as determined by visual analog scale \< 4
  2. * Chronic renal insufficiency (serum creatinine \>2 mg/dL)
  3. * Allergy to iodinated contrast agents that is not responsive to steroid management
  4. * Active Infection or malignancy
  5. * Prior elbow surgery in the subject elbow
  6. * Uncorrectable bleeding diathesis

Contacts and Locations

Study Contact

Aniket Joglekar
CONTACT
310-948-8026
AJoglekar@mednet.ucla.edu
Siddharth A Padia, M.D.
CONTACT
310-481-7545
SPadia@mednet.ucla.edu

Principal Investigator

Siddharth Padia, M.D.
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Siddharth Padia, MD

  • Siddharth Padia, M.D., PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-21
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2023-03-21
Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

  • tennis elbow
  • embolization
  • embozene

Additional Relevant MeSH Terms

  • Lateral Epicondylitis, Unspecified Elbow