Achilles Tendinopathy Embolization (ATE) With LipioJoint: An Early Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pain Change
研究概览
简要总结
The goal of this clinical trial is to learn determine the feasibility of arterial embolization using Lipiodol emulsion to safely and effectively treat chronic Achilles tendon pain due to Achilles tendinopathy in adults aged 25 to 80. The main questions it aims to answer are:
- Does this procedure successfully reduce chronic Achilles tendon pain as measured by the Visual Analog Scale (VAS) over 12 months?
- How safe is the procedure, specifically regarding the frequency of serious medical problems or adverse events related to the device?
Participants will:
- Undergo a minimally invasive procedure where a doctor uses a small tube (catheter) to inject a temporary blocking agent (LipioJoint) into specific blood vessels supplying the Achilles tendon.
- Receive a phone call one day after the procedure to check for early side effects.
- Participate in four follow-up visits over the course of one year (at 1, 3, 6, and 12 months).
Complete pain intensity surveys (VAS) and report any changes in their use of other therapies or medications during these visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 25 years
- •Subject provides written informed consent
- •Patient with Achilles tendinopathy refractory to 3 months of conservative management
- •Self reported pain of at least 4/10 on visual analog scale (VAS)
- •Non-surgical candidate/looking to avoid surgery
排除标准
- •Achilles tendon pain caused by acute fracture, recent trauma, inflammatory conditions, muscle/ligament injury, tendon rupture, and etiologies related to bone mineral density
- •Steroid injection in the last 90 days from the embolization procedure
- •Known severe allergy to Lipiodol and/or iodinated contrast media
- •Diagnosis of peripheral arterial disease affecting the lower extremities
- •Pregnancy or breastfeeding
- •Anticoagulation or irreversible coagulopathy
- •GFR <45 or Serum creatinine > 2.0 mg/dl
- •Type 1 Diabetes Mellitus
研究组 & 干预措施
Experimental: Achilles Tendonopathy Embolization
干预措施: LipioJoint (Device)
结局指标
主要结局
Pain Change
时间窗: Baseline to 12 months
Pain - measured via visual analogue scale at baseline, 1-month, 3-month, 6-month, and 12-month follow-up
Safety (rate of adverse events)
时间窗: Baseline to 12 month follow-up
Safety - Percentage of subjects without serious adverse events related to the medical device
次要结局
未报告次要终点