Clinical trial NCT05325242: Elbow Artery Embolization for Tennis Elbow
Official title: Safety and Efficacy of Elbow Artery Embolization (EAE) for the Treatment of Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Epicondylitis, Unspecified Elbow
Keywords: tennis elbow
embolization
embozene
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Changes in Visual Analog Scan (VAS) as a measure of efficacy
timeFrame: 24 months
measure: Change in symptoms as assessed by the QuickDASH scores.
timeFrame: 24 months
measure: Change in symptoms as assessed by the patient-rates tennis elbow evaluation (PRTEE) scores.
timeFrame: 24 months
measure: Change in imaging
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Siddharth Padia, M.D.
role: PRINCIPAL_INVESTIGATOR
References: