Zephyr Etude Post-Inscription (French Registry)

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04517916
Study type	Observational [Patient Registry]
Source	Pulmonx Corporation
Contact
Status	Active, not recruiting
Phase
Start date	January 4, 2021
Completion date	September 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06000696` - Healthy at Home Pilot
Recruiting	`NCT03285100` - The Effects of Discontinuation of Vitamin K Antagonists on the Rate of Elastin Degradation	N/A
Not yet recruiting	`NCT05900544` - Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures	N/A
Recruiting	`NCT06163131` - The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
Recruiting	`NCT06149494` - RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection	Phase 2
Recruiting	`NCT05854550` - First in Human Study to Assess an Implant to Treat Severe Emphysema	N/A
Recruiting	`NCT05257681` - Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction	N/A
Recruiting	`NCT06068647` - Ultrasound and Respiratory Physiological Signals in Lung Diseases	N/A
Recruiting	`NCT03318406` - Post-Market BTVA Registry
Recruiting	`NCT04214587` - Biological Investigation of Explanted Endobronchial Lung Valves Study
Completed	`NCT03205826` - Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia	N/A
Recruiting	`NCT04781582` - LVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial	N/A
Completed	`NCT04520152` - Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema	N/A
Recruiting	`NCT03680495` - Steroid Resistance During COPD Exacerbations With Respiratory Failure
Recruiting	`NCT06249529` - Airway Bypass - Safety and Feasibility Study	Early Phase 1
Recruiting	`NCT06035120` - An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema	N/A
Recruiting	`NCT05567562` - Anti-Platelets in Chronic Obstructive Pulmonary Disease	Phase 2
Withdrawn	`NCT04029077` - Introduction of the Vapor Treatment in The Netherlands
Recruiting	`NCT03755505` - The Microbiome of Sputum, Urine and Feces in Healthy Persons and Chronic Obstructive Pulmonary Disease (COPD) Patients
Completed	`NCT03670121` - A Pilot Study to Assess Treatment of Patients With Homogeneous Emphysema Using Sequential Segmental Bronchoscopic Thermal Vapor Ablation (NEXT STEP)	N/A