NCT04071509已完成不适用
Pilot Study on the Prevention of PNX (Pneumothorax) and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Procedures Using the MIPP-Kit Device.
BetaGlue Technologies spa6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Rate of complications associated with percutaneous lung biopsy
研究概览
简要总结
The study will assess the safety and feasibility of a new medical device, MIPP-Kit, for the prevention of complications during diagnostic, CT guided ,percutaneous lung needle biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical indication for diagnostic percutaneous lung biopsy
排除标准
- •Pregnant, or breastfeeding patient (Female)
- •actively participating in other clinical trials in the previous 30 days
- •known allergies to the investigational device components
- •comorbidities that preclude undergoing percutaneous lung biopsy procedure
- •concomitant treatments that preclude undergoing percutaneous lung biopsy procedure
结局指标
主要结局
Rate of complications associated with percutaneous lung biopsy
时间窗: 48 hours after procedure
incidence of clinical complications commonly associated with lung biopsy (pneumothorax and haemorrhage)
次要结局
未报告次要终点
研究者
研究点 (6)
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