Zephyr Etude Post-Inscription (French Registry)

Status Active, not recruiting

Clinical Trial Summary

The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.

Clinical Trial Description

This is a multi-center, single-arm, prospective Registry to be conducted at a minimum of 12 study centers. Approximately 150 patients with severe emphysema undergoing Zephyr Valve treatment will be enrolled and followed out to 3 years. Assessments will be performed at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure. Patients prescribed the Zephyr Valve treatment will be consented and will be enrolled only after determination of little to no collateral ventilation between target and ipsilateral lobes. Safety and effectiveness of the Zephyr Valve treatment will be evaluated post-treatment based on data collected out to 3-years post-treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04517916
Study type	Observational [Patient Registry]
Source	Pulmonx Corporation
Contact
Status	Active, not recruiting
Phase
Start date	January 4, 2021
Completion date	September 30, 2025

View Details

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