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

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ClinicalTrials.gov Identifier: NCT01166516
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Spiration, Inc.

July 13, 2010
July 21, 2010
April 17, 2018
April 2010
March 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01166516 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002 - Post Approval Study
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prolonged Air Leak
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
Treatment with HUD IBV Valve System
Treatment with HUD IBV Valve System in Post-Approval Study
Intervention: Device: Treatment with HUD IBV Valve System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Same as current
July 2017
March 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01166516
CPR-02704
No
Not Provided
Not Provided
Spiration, Inc.
Spiration, Inc.
Not Provided
Principal Investigator: Douglas E. Wood, MD University of Washington
Spiration, Inc.
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP