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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Treatment involves placing one or more valves in the airways of the lung to control a prolonged air leak.
Piedmont Hospital
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
SIU School of Medicine
Springfield, Illinois, United States
Olathe Medical Center
Olathe, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Lahey Clinic
Burlington, Massachusetts, United States
Cleveland Clinic
Cleveland, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
...and 3 more locations
Safety
The primary objective of this study is to characterize the device safety profile. Adverse events (AEs) reported during the study will be analyzed and summarized. This information will be used to enhance the HDE device labeling.
Time frame: Day 0 to 6 weeks
Probable Benefit
Secondary study objectives are to gather probable benefit information regarding reduction in air leaks and reduction in health care utilization to support potential future premarket applications. The response of the air leak to valve treatment will be observed and recorded along with the time of observation. Probable benefit information gathered during the study will be analyzed and summarized
Time frame: Day 0 to 6 weeks
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