NCT02521129Unknown1 期
A New Track Ablation Device for Liver Biopsy: A Feasibility Study
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 主要终点
- Number of participants with complications
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of a new biopsy track ablation device for liver biopsy.
详细描述
Background:
- Percutaneous biopsy for hepatic masses has a potential risk of bleeding and peritoneal tumor seeding.
- A new device for biopsy track ablation has been invented to reduce the risk of bleeding and peritoneal tumor seeding.
Method:
- Routine percutaneous biopsy for hepatic masses is performed.
- Immediate after obtaining tissue, biopsy needle track is ablated with a new biopsy tract ablator.
- Immediate (with ultrasound) and 24 hours (with CT scan) after procedure, occurrence of complications is evaluated.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a hepatic mass on CT scan or MRI
- •patients who are referred for percutaneous biopsy of a hepatic mass
- •patients with normal range of platelet count and coagulation test
排除标准
- •pregnant women
- •patients with ascites
- •Uncooperative patients
结局指标
主要结局
Number of participants with complications
时间窗: within 24 hours after procedure
If procedure-related complications are suspected clinically, appropriate tests such as CT scan or Ultrasound are performed and complications are evaluated. If procedure-related complications are not suspected, non-contrast CT scan is performed at 24 hours after procedure and complications are evaluated.
次要结局
未报告次要终点
研究者
Hyunchul Rhim
professor
Samsung Medical Center
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