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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Spiration, Inc.
Information provided by (Responsible Party):
Spiration, Inc.
ClinicalTrials.gov Identifier:
First received: July 13, 2010
Last updated: February 26, 2015
Last verified: February 2015

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: Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 32
Study Start Date: April 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: May 2015 (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


Genders Eligible for Study:   Both
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 ClinicalTrials.gov identifier: NCT01166516

Contact: Doug Sheffield, VMD, PhD 425-497-1700 ext 234 dsheffield@spiration.com

United States, Georgia
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Elizabeth Wilkins         
Principal Investigator: Saeid Khansarinia, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60561
Contact: Cyndy Warnes         
Principal Investigator: Kyle Hogarth, MD         
SIU School of Medicine Recruiting
Springfield, Illinois, United States, 62794
Contact: Theresa Boley    217-788-4204      
Principal Investigator: Stephen Hazelrigg, MD         
United States, Kansas
Olathe Medical Center Recruiting
Olathe, Kansas, United States, 66061
Contact: Jeannie Zirkle         
Principal Investigator: Dennis Lawlor, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Connie Dampier         
Principal Investigator: Timothy Mullett, MD         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Lonny Yarmus         
Principal Investigator: Lonny Yarmus, MD         
United States, Massachusetts
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Joyce Pelletier         
Principal Investigator: Ghazwan Acash, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Yvonne Meli         
Principal Investigator: Michael Machuzak, MD         
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: MaryCatherine Hess    717-531-6010      
Contact: Terry Novchich    (717) 531-1389      
Principal Investigator: Jennifer Toth, MD         
United States, Texas
UT Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Megha Sharma    214-645-9730    megha.sharma@stsouthwestern.edu   
Principal Investigator: Muhanned Abu-Hijleh, MD         
Michael DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Sarah Perusich    713-794-7294      
Principal Investigator: Roberto Casal, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Christina Brennan         
Principal Investigator: Jed Gorden, MD         
University of Washington Recruiting
Seattle, Washington, United States, 98115
Contact: Linda Harrison    206-221-3341      
Principal Investigator: Doug Wood, MD         
Sponsors and Collaborators
Spiration, Inc.
Principal Investigator: Douglas E. Wood, MD University of Washington
  More Information

No publications provided

Responsible Party: Spiration, Inc.
ClinicalTrials.gov Identifier: NCT01166516     History of Changes
Other Study ID Numbers: CPR-02704
Study First Received: July 13, 2010
Last Updated: February 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Spiration, Inc.:
Prolonged air leak
lung volume reduction surgery (LVRS)

ClinicalTrials.gov processed this record on October 09, 2015