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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prolonged Air Leak

Intervention / Treatment
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* Device: Treatment with HUD IBV Valve System


Participation Criteria
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Eligibility Criteria
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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
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment with HUD IBV Valve System<br>Treatment with HUD IBV Valve System in Post-Approval Study | Device: Treatment with HUD IBV Valve System<br>* Treatment involves placing one or more valves in the airways of the lung to control a prolonged air leak.<br>* Other names: IBV Valve System;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prolonged air leak, lobectomy, segmentectomy, lung volume reduction surgery (LVRS)