Zephyr Etude Post-Inscription (French Registry)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04517916

Enrollment

155

Registered

2020-08-19

Start date

2021-01-04

Completion date

2026-01-28

Last updated

2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emphysema or COPD

Brief 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.

Detailed 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.

Interventions

DEVICEZephyr Valve

Subjects prescribed Zephyr Valve treatment for their emphysema/COPD and treated with the Zephyr Valves.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with emphysema (COPD Grade III and Grade IV) considered appropriate for the bronchoscopic lung volume reduction procedure by the physician. * Subjects who signed an Informed Consent Form to allow data collection.

Exclusion criteria

* Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).

Design outcomes

Primary

Measure	Time frame	Description
Forced Expiratory Volume in 1 second (FEV1)	12 months	The percent of patients achieving an improvement in the post-bronchodilator FEV1 of ≥12% at 12-months.

Secondary

Measure	Time frame	Description
Treated Lobar Volume Reduction (TLVR)	45 days	Treated Lobar Volume Reduction (TLVR) assessed by High Resolution Computed Tomography (HRCT) at 45-days.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORThomas Egenod, MD

Hôpital Dupuytren (CHRU Limoges)

STUDY_DIRECTORDennis McHugh

Pulmonx Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026