IBV Valve System for the Treatment of Prolonged Air Leak Under HDE H060002

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2017-07-31

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.

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Detailed Description

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Conditions

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Prolonged Air Leak

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with HUD IBV Valve System

Treatment with HUD IBV Valve System in Post-Approval Study

Group Type OTHER

Treatment with HUD IBV Valve System

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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IBV Valve System

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No