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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Spiration, Inc.
ClinicalTrials.gov Identifier:
NCT01166516
First received: July 13, 2010
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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: October 2013
Estimated Primary Completion Date: October 2013 (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

Detailed Description:

Primary Study Objective - 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.

Secondary Study Objectives - 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166516

Sponsors and Collaborators
Spiration, Inc.
Investigators
Principal Investigator: Douglas E. Wood, MD University of Washington
  More Information

Additional Information:
sponsor's web site  This link exits the ClinicalTrials.gov site

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: December 11, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013