Pulmonary Emphysema
Conditions
Keywords
Valves, Endobronchial, Endoscopic lung volume reduction, Pulmonx, Zephyr, Chartis, Emphysema, COPD
Brief summary
This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.
Detailed description
Primary objective is pulmonary function as assessed by FEV1 and secondary objectives are health related quality of life as assessed by the modified MRC dyspnea score and by the COPD assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in Germany. Patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. The study will observe normal clinical practice. No investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. Patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. Zephyr Endobronchial Valve has CE mark and is fully reimbursed in Germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice.
Interventions
DEVICEZephyr Endobronchial Valve (EBV)
• Implantation of at least one Zephyr EBV following Chartis assessment
Sponsors
Pulmonx International Sàrl
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of both genders of at least 18 years of age * Understand and voluntarily sign an informed consent form. * FEV1 \> 15% predicted and \< 45% predicted * RV \>180% predicted * Diagnosis of emphysema with CT evidence of hyperinflation . Absence of collateral ventilation according to Chartis Assessment System
Exclusion criteria
• Active pulmonary infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 | 2 years | Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Medical Research Council (mMRC) Questionnaire | 5 years | Absolute and relative change from baseline at each visit over the 5 year period of the Modified Medical Research Council (mMRC) Score |
| COPD Assessment Test (CAT) | 5 years | Absolute and relative change from baseline at each visit over the 5-year period for the COPD Assessment Test (CAT) |
| Survival over 5 years | 5 years | Survival status over the 5 year study period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 5 years | Tabulation of adverse events occuring over the 5 year study period |
Countries
Germany
Outcome results
None listed