IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study
- Conditions
- Prolonged Air Leak
- Interventions
- Device: Treatment with HUD IBV Valve System
- Registration Number
- NCT01166516
- Lead Sponsor
- Olympus Corporation of the Americas
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment with HUD IBV Valve System Treatment with HUD IBV Valve System Treatment with HUD IBV Valve System in Post-Approval Study
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (13)
University of Chicago
🇺🇸Chicago, Illinois, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Olathe Medical Center
🇺🇸Olathe, Kansas, United States
SIU School of Medicine
🇺🇸Springfield, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Michael DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States