Clinical trial NCT01166516: IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study
Official title: A Prospective Study With the IBV Valve System for the Treatment of Prolonged Air Leak
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Air Leak
Keywords: Prolonged air leak
lobectomy
segmentectomy
lung volume reduction surgery (LVRS)
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
First posted: 2010-07-21
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: Day 0 to 6 weeks
Secondary outcomes:
measure: Probable Benefit
timeFrame: Day 0 to 6 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Olathe
country: United States
facility: Olathe Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Michael DeBakey VA Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Douglas E. Wood, MD
role: PRINCIPAL_INVESTIGATOR
References: