Zephyr Etude Post-Inscription (French Registry)

Active, not recruiting

• Conditions: Emphysema or COPD
• Interventions: Device: Zephyr Valve

• Registration Number: NCT04517916
• Lead Sponsor: Pulmonx Corporation

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.

Study Timeline

• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-19
• Study Start: 2021-01-04
• Primary Completion: 2022-06-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 155

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Zephyr Valve treatment	Zephyr Valve	Patients undergoing the Zephyr Valve treatment for emphysema/COPD

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (11)

Hôpital François Mitterrand; 🇫🇷 Dijon, France

Hôpital Dupuytren; 🇫🇷 Limoges, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Hôpital Larrey; 🇫🇷 Toulouse, France

Hôpital La Cavale Blanche; 🇫🇷 Brest, France

Hôpital Nord; 🇫🇷 St. Etienne, France

Hôpital Calmette; 🇫🇷 Lille, France

Hôpital Bichat; 🇫🇷 Paris, France

Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France