Overview

This trial is active, not recruiting.

Condition pulmonary emphysema
Treatment zephyr endobronchial valve (ebv)
Sponsor Pulmonx International Sàrl
Start date July 2012
End date August 2017
Trial size 2000 participants
Trial identifier NCT01580215, 630-0013

Summary

This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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
zephyr endobronchial valve (ebv)
• Implantation of at least one Zephyr EBV following Chartis assessment

Primary Outcomes

Measure
FEV1
time frame: 2 years

Secondary Outcomes

Measure
Modified Medical Research Council (mMRC) Questionnaire
time frame: 5 years
COPD Assessment Test (CAT)
time frame: 5 years
Survival over 5 years
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Long Term Follow up Investigation of Endobronchial Valves in Emphysema
Principal investigator Felix JF Herth, Prof. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Pulmonx, Inc..