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

Olympus

Status

Completed

Conditions

Prolonged Air Leak

Treatments

Device: Treatment with HUD IBV Valve System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01166516

CPR-02704

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Volunteers

No Healthy Volunteers

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