NCT01166516

IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study

A Prospective Study With the IBV Valve System for the Treatment of Prolonged Air Leak

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Olympus Corporation of the Americas · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Study to collect post-market safety data for HUD IBV Valve System, 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 LVRS. An air leak present on post-operative 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.

Conditions

• Prolonged Air Leak

Interventions

Type	Name	Description
DEVICE	Treatment with HUD IBV Valve System	Treatment involves placing one or more valves in the airways of the lung to control a prolonged air leak.

Timeline

• Start date: 2010-04-01
• Primary completion: 2016-03-01
• Completion: 2017-07-01
• First posted: 2010-07-21
• Last updated: 2018-04-17

Locations

13 sites across 1 country: United States