NCT01221493Unknown不适用
EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions
详细描述
Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy.
Until now, the use of the cryoprobe ism´t show in peripheral lung tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •solitary pulmonary nodule < 4 cm
- •no endobronchial lesion
- •indication for bronchoscopy
排除标准
- •coagulopathy
- •pulmonary hypertension
- •pregnancy
研究组 & 干预措施
Cryo biospy
Experimental
干预措施: Cryo biopsy (Procedure)
结局指标
主要结局
Safety
时间窗: 24 h after intervention
Number of Participants with Adverse Events as a Measure of Safety Detailed analysis of number of Pneumothoraces and number of bleeding complication
次要结局
- Efficacy(48 h after intervention)
研究者
研究点 (1)
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