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Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion — COVE  

Pulmonary Emphysema Clinical Trial

Official title:
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

Clinical Trial Summary

Prospective, multi-centre, pilot study aimed to evaluate the effect of Video Assisted Thoracic Surgery (VATS) fissure completion on the efficacy of endobronchial valve insertion (Zephyr Valve) in the treatment of subjects with severe Chronic Obstructive Pulmonary Disease (COPD) who exhibit collateral ventilation.

Clinical Trial Description

The study will be a prospective, multi-centre, pilot study aimed to evaluate the effect of VATS fissure completion on the efficacy of endobronchial valve insertion (Zephyr Valve) in the treatment of subjects with severe COPD who exhibit collateral ventilation. Study patients who provide informed consent and meet the initial inclusion/exclusion criteria following baseline screening assessments and multidisciplinary review to determine eligibility will undergo two procedures, not less than 28 days apart. The first procedure will involve an initial bronchoscopy and Chartis® assessment of collateral ventilation under general anaesthesia followed by a VATS fissure completion between targeted lobes in subjects that have collateral ventilation. The second procedure undertaken following fissure completion surgery will involve bronchoscopic insertion of Zephyr® Valve(s) in the targeted lobe, under sedation or general anaesthesia. Subjects will be followed up over a 6-month period following VATS fissure completion and Zephyr® Endobronchial Valve (Zephyr Valve) insertion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04465461
Study type Interventional
Source Pulmonx Corporation
Contact
Status Active, not recruiting
Phase N/A
Start date June 4, 2020
Completion date August 30, 2024
View Details
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