Long Term Follow up Investigation of Endobronchial Valves in Emphysema

Terminated

• Conditions: Pulmonary Emphysema
• Interventions: Device: Zephyr Endobronchial Valve (EBV)

• Registration Number: NCT01580215
• Lead Sponsor: Pulmonx International Sàrl

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.

Study Timeline

• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-18
• Study Start: 2012-07
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-21
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 628

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main cohort	Zephyr Endobronchial Valve (EBV)	* Patients of both genders of at least 18 years of age * Who 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 * Treated with Zephyr Endobronchial Valve (EBV)

Primary Outcome Measures

Name	Time	Method
FEV1	2 years	Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)

Secondary Outcome Measures

Name	Time	Method
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
Survival over 5 years	5 years	Survival status over the 5 year study period
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)

Trial Locations

Locations (1)

Heidelberg Hospital; 🇩🇪 Heidelberg, Germany