Feasibility of Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for the Treatment of Venous Malformations.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of patients for whom the procedure is successful
研究概览
简要总结
The aim of this study is to evaluate the feasibility of assisted electromagnetic navigation in percutaneous echo-guided sclerotherapy of slow-flow vascular malformations. Feasibility will be defined in terms of the percentage of patients for whom the procedure is successful.
详细描述
Primary interventional treatment of low flow vascular anomalies includes ultrasound guided foam sclerotherapy. Each procedure involves a percutaneous needle insertion. However, procedures remain complicated to obtain the right trajectory in order to inject the foam at the center of the abnormality. Electromagnetic navigation system tracks the operator's needle, meaning the position and progression of the needle is visualized in 3D real time on the ultrasound probe interface.
The present trial evaluate the feasibility of the electromagnetic navigation system during the needle insertion and the improvement of needle placement accuracy.
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
- •Low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI
- •Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting
排除标准
- •patients with pacemakers or internal defibrillator
- •patients with ferromagnetic implanted material
- •patients who are wards of court or under guardianship
- •patients deprived of freedom by judicial or administrative decision
- •patients under legal protection
- •pregnant women
结局指标
主要结局
Percentage of patients for whom the procedure is successful
时间窗: day 1
Success of procedure a.e. obtention of venous flow at the extremity of the needle permitting the realization of the foam sclerotherapy treatment.
次要结局
- Estimate the time to complete catheterization of the malformation(day 1)
- Estimate the number of punctures required to achieve catheterization of the malformation.(day 1)
- Estimate the undesirable effects associated with assisted electromagnetic navigation.(day 1)