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

Completed · Not applicable

Conditions studied: Prolonged Air Leak

In brief

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.

Key facts

Study ID

NCT01166516

Run by

Olympus Corporation of the Americas

People needed

32

Starts

2010-04-01

Expected to finish

2017-07-01

Last updated by the study team

2018-04-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Michael DeBakey VA Medical Center — Houston, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.