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

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.

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Key information

Conditions

Prolonged Air Leak

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piedmont Hospital, Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment with HUD IBV Valve System

Device

Treatment involves placing one or more valves in the airways of the lung to control a prolonged air leak.

Other names: IBV Valve System

Primary outcomes

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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Olympus Corporation of the Americas

Industry

Registry information

Official study title

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

Acronym: HUD-PAS

Important dates

Study start: 2010
Primary completion: 2016
Study completion: 2017
First posted: Jul 21, 2010
Registry last updated: Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed