Prolonged Air Leak
Conditions
Keywords
Prolonged air leak, lobectomy, segmentectomy, lung volume reduction surgery (LVRS)
Brief 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.
Interventions
DEVICETreatment with HUD IBV Valve System
Treatment involves placing one or more valves in the airways of the lung to control a prolonged air leak.
Sponsors
Olympus Corporation of the Americas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subject has an air leak present on day 7 after lobectomy, segmentectomy, or lung volume reduction surgery (LVRS), or on day 5 if the air leak 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
Exclusion criteria
* Air leak only on force exhalation or cough * Subject has significant active asthma, pneumonia, bacterial bronchitis or clinically significant bronchiectasis * Subject is unable to provide informed consent and there is no designated authority to sign for the incapacitated patient * Subject is not an appropriate candidate for, or unable to tolerate, flexible bronchoscopy procedures * Subject has co-morbidities or factors that will prevent follow-up during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Day 0 to 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probable Benefit | Day 0 to 6 weeks | 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 |
Countries
United States
Outcome results
None listed