Long Term Follow up Investigation of Endobronchial Valves in Emphysema

Pulmonary Emphysema Clinical Trial

— LIVE  

Official title:

Long Term Follow up Investigation of Endobronchial Valves in Emphysema

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01580215
• Other study ID #: 630-0013
• Status: Terminated
• Phase: N/A
• First received: April 17, 2012
• Last updated: December 21, 2017
• Start date: July 2012
• Est. completion date: September 2016

Study information

• Verified date: December 2017
• Source: Pulmonx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 628
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Device:
• Zephyr Endobronchial Valve (EBV)
• Implantation of at least one Zephyr EBV following Chartis assessment

Locations

Country	Name	City	State
Germany	Heidelberg Hospital	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Pulmonx International Sàrl

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Tabulation of adverse events occuring over the 5 year study period	5 years
Primary	FEV1	Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)	2 years
Secondary	Modified Medical Research Council (mMRC) Questionnaire	Absolute and relative change from baseline at each visit over the 5 year period of the Modified Medical Research Council (mMRC) Score	5 years
Secondary	COPD Assessment Test (CAT)	Absolute and relative change from baseline at each visit over the 5-year period for the COPD Assessment Test (CAT)	5 years
Secondary	Survival over 5 years	Survival status over the 5 year study period	5 years