NCT02028052终止不适用
Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE) by Cytopathologist
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Time lapse
研究概览
简要总结
The objective of this study is comparing the attributable procedural time of Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and hilar lymph nodes with or without Rapid On-Site Evaluation (ROSE). The primary outcome will be the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. Secondary outcomes will include total number of sampled lymph nodes, average number of needle aspirations per lymph node sampled, overall diagnostic yield, and procedural time of the cytopathologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Subject provides informed consent
- •Subject is >18 years of age
- •Subject is scheduled to undergo flexible bronchoscopy with EBUS-TBNA of suspected enlarged mediastinal or hilar lymph nodes as part of their standard medical care
- •A negative pregnancy test in women of child-bearing potential
- •Subject is mentally capable of following study directions
排除标准
- •Study subject has any disease or condition that interferes with safe completion of initial or follow-up assessments
- •Concurrent participation in another study involving investigational drugs or investigational medical devices
- •Inability to read and understand the necessary study documents
结局指标
主要结局
Time lapse
时间窗: during procedure, approximately 45 minutes
The primary endpoint is the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal.
次要结局
- Overall diagnostic yield(approximately 45 minutes)
- Procedural time of the cytopathologist(approximately 30 minutes)
- Total number of sampled lymph nodes(approximately 45 minutes)
- Average number of needle aspirations per lymph node sampled(approximately 45 minutes)
研究者
研究点 (2)
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