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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01580215
Other study ID # 630-0013
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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