跳至主要内容
临床试验/NCT01872312
NCT01872312撤回不适用

The Humanatarian Use of the Spiration IBV® Valve System and Spiration Airway Sizing Kit for Use in Patients at The Ohio State University Medical Center.

Ohio State University2 个研究点 分布在 1 个国家开始时间: 2012年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
resolution of BPF (Bronchopleural Fistulae)

研究概览

简要总结

This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.

详细描述

IBV® Valve System The Spiration® IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to 6 weeks per prolonged air leak.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unresolved BPF
  • Not candidate for surgical repair

排除标准

  • 未提供

结局指标

主要结局

resolution of BPF (Bronchopleural Fistulae)

时间窗: 6 weeks

expected resolution of BPF (Bronchopleural Fistulae) in three weeks

resolutin of BPF

时间窗: 6 weeks

anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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