Zephyr Etude Post-Inscription (French Registry)

N/AActive Not RecruitingNCT04517916

Pulmonx Corporation155 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

155

Conditions

Emphysema or COPD

Interventions

Zephyr ValveDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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).

Locations (12)

Hôpital La Cavale Blanche

Brest, France

Hôpital François Mitterrand

Dijon, France

Hôpital Nord

Latronche, France

Hôpital Calmette

Lille, France

Outcomes

Primary Outcomes

Forced Expiratory Volume in 1 second (FEV1)

The percent of patients achieving an improvement in the post-bronchodilator FEV1 of ≥12% at 12-months.

Time frame: 12 months

Secondary Outcomes

Treated Lobar Volume Reduction (TLVR)

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

Time frame: 45 days

Data from ClinicalTrials.gov

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