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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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Hôpital La Cavale Blanche
Brest, France
Hôpital François Mitterrand
Dijon, France
Hôpital Nord
Latronche, France
Hôpital Calmette
Lille, France
Hôpital Dupuytren
Limoges, France
Hôpital Arnaud de Villeneuve
Montpellier, France
Hôpital Bichat
Paris, France
Hôpital Cochin
Paris, France
Hôpital Charles Nicolle
Rouen, France
Hôpital Nord
Saint-Etienne, France
Start Date
January 4, 2021
Primary Completion Date
June 22, 2022
Completion Date
January 28, 2026
Last Updated
February 18, 2026
155
ACTUAL participants
Zephyr Valve
DEVICE
Lead Sponsor
Pulmonx Corporation
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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