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临床试验/NCT01221493
NCT01221493Unknown不适用

EBUS Guided Cryo Biopsy of Solitary Pulmonary Nodules

Heidelberg University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
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

入选标准

  • solitary pulmonary nodule < 4 cm
  • no endobronchial lesion
  • indication for bronchoscopy

排除标准

  • coagulopathy
  • pulmonary hypertension
  • pregnancy

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

申办方类型
Other

研究点 (2)

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