A pilot study of Video Assisted Thoracic Surgery (VATS) fissure completion prior to Zephyr® Endobronchial Valve insertion for severe Chronic Obstructive Pulmonary Disease (COPD) in patients with COllateral VEntilation

Pulmonx Australia Pty. Ltd.0 sites9 target enrollmentMay 20, 2019

Overview

No summary available.

Registry

who.int

Start Date

May 20, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Pulmonx Australia Pty. Ltd.

•1\. Subject is willing and able to provide informed consent and to participate in the study.
•2\. Subject is greater than or equal to 40 years of age.
•3\. Subject has a diagnosis of severe or very severe homogenous or heterogeneous COPD (GOLD classification1\).
•4\. Subject has a post bronchodilator FEV1 of greater than or equal to 15% and less than or equal to 50%.
•5\. Subject has TLC \> 100% predicted.
•6\. Subject has RV \> 175% predicted.
•7\. Subject has a normal dobutamine stress echocardiogram.
•8\. Subject has sufficient exercise tolerance i.e. 6MWT is greater than or equal to 150m and less than or equal to 450m.
•9\. Subject has an incomplete lobar fissure i.e. \< 90%, as confirmed by CT evaluation of lung fissures.
•10\. Collateral ventilation confirmed as assessed by Chartis Assessment (to be confirmed during first procedure/operation)

•1\. Subject has a history of previous thoracotomy, lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any form.
•2\. Subject has an acute COPD exacerbation.
•3\. Subject has evidence of active respiratory infection.
•4\. Subject has a post bronchodilator FEV1 \< 15%.
•5\. Subject has a DLCO \< 20%.
•6\. Subject has a history of recurrent clinically significant respiratory infections, defined as three (3\) or more COPD exacerbations requiring hospitalisation during the 12 months prior to study enrolment (ICF signature page).
•7\. Subject has severe gas exchange abnormalities as defined by any one of the following:
•a. PaO2 \< 60 mmHg
•b. PaCO2 \> 45 mmHg on room air
•c. SpO2 \< 90% on less than or equal to 4 L/min supplemental O2 at rest