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

This study has been completed.
Information provided by (Responsible Party):
Spiration, Inc. Identifier:
First received: July 13, 2010
Last updated: April 12, 2016
Last verified: April 2016
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.

Condition Intervention
Prolonged Air Leak
Device: Treatment with HUD IBV Valve System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study With the IBV Valve System for the Treatment of Prolonged Air Leak

Further study details as provided by Spiration, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 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:
  • Probable Benefit [ Time Frame: 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

Enrollment: 32
Study Start Date: April 2010
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment with HUD IBV Valve System
Treatment with HUD IBV Valve System in Post-Approval Study
Device: Treatment with HUD IBV Valve System
Treatment involves placing one or more valves in the airways of the lung to control a prolonged air leak.
Other Name: IBV Valve System


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01166516

United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60561
SIU School of Medicine
Springfield, Illinois, United States, 62794
United States, Kansas
Olathe Medical Center
Olathe, Kansas, United States, 66061
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Michael DeBakey VA Medical Center
Houston, Texas, United States, 77030
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
University of Washington
Seattle, Washington, United States, 98115
Sponsors and Collaborators
Spiration, Inc.
Principal Investigator: Douglas E. Wood, MD University of Washington
  More Information

Responsible Party: Spiration, Inc. Identifier: NCT01166516     History of Changes
Other Study ID Numbers: CPR-02704
Study First Received: July 13, 2010
Last Updated: April 12, 2016

Keywords provided by Spiration, Inc.:
Prolonged air leak
lung volume reduction surgery (LVRS) processed this record on May 23, 2017