Safety and Efficacy of Elbow Artery Embolization (EAE) for the Treatment of Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Embozene particles (Device)
结局指标
主要结局
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.
时间窗: 12 months
Changes in QuickDASH (Disabilities of the Arm, Shoulder, and Hand) score as a measure of efficacy.
次要结局
- 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)
研究者
Siddharth Padia, MD
Professor of Radiology
University of California, Los Angeles