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

Prolonged Air Leak Clinical Trial

— HUD-PAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166516
• Other study ID #: CPR-02704
• Status: Completed
• Phase: N/A
• First received: July 13, 2010
• Last updated: April 16, 2018
• Start date: April 2010
• Est. completion date: July 2017

Study information

• Verified date: April 2018
• Source: Spiration, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prolonged Air Leak

Intervention

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.

Locations

Country	Name	City	State
United States	Piedmont Hospital	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Lahey Clinic	Burlington	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Michael DeBakey VA Medical Center	Houston	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	Olathe Medical Center	Olathe	Kansas
United States	Swedish Medical Center	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	SIU School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Spiration, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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