NCT04517916

Zephyr Etude Post-Inscription (French Registry)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Pulmonx Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Emphysema or COPD

Interventions

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

Timeline

• Start date: 2021-01-04
• Primary completion: 2022-06-22
• Completion: 2026-01-28
• First posted: 2020-08-19
• Last updated: 2026-02-18

Locations

12 sites across 1 country: France