Status:
COMPLETED
IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study
Lead Sponsor:
Olympus Corporation of the Americas
Conditions:
Prolonged Air Leak
Eligibility:
All Genders
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01166516
Start Date
April 1 2010
End Date
July 1 2017
Last Update
April 17 2018
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Piedmont Hospital
Atlanta, Georgia, United States, 30309
2
University of Chicago
Chicago, Illinois, United States, 60561
3
SIU School of Medicine
Springfield, Illinois, United States, 62794
4
Olathe Medical Center
Olathe, Kansas, United States, 66061