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Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms

  • Fistula
  • Management of BPF (Bronchopleural Fistulae)

NCT number NCT01872312
Study type Interventional
Source Ohio State University
Contact
Status Withdrawn
Phase N/A
Start date March 25, 2012
Completion date February 14, 2014