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

A Prospective Study With the IBV Valve System for the Treatment of Prolonged Air Leak

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.

Study Overview

• Status: Completed
• Conditions: Prolonged Air Leak
• Intervention / Treatment: Device: Treatment with HUD IBV Valve System

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
  • Illinois
    • Chicago, Illinois, United States, 60561
      • University of Chicago
    • Springfield, Illinois, United States, 62794
      • SIU School of Medicine
  • Kansas
    • Olathe, Kansas, United States, 66061
      • Olathe Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
  • Texas
    • Dallas, Texas, United States, 75235
      • UT Southwestern Medical Center at Dallas
    • Houston, Texas, United States, 77030
      • Michael Debakey VA Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center
    • Seattle, Washington, United States, 98115
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: IBV Valve System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	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.	Day 0 to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probable Benefit	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	Day 0 to 6 weeks

Collaborators and Investigators

• Sponsor: Spiration, Inc.
• Investigators: Principal Investigator: Douglas E. Wood, MD, University of Washington

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: July 13, 2010
• First Submitted That Met QC Criteria: July 19, 2010
• First Posted (Estimate): July 21, 2010

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: segmentectomy; lobectomy; Prolonged air leak; lung volume reduction surgery (LVRS)
• Other Study ID Numbers: CPR-02704