NCT01580215

Long Term Follow up Investigation of Endobronchial Valves in Emphysema

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 628 (actual)
• Sponsor: Pulmonx International Sàrl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Emphysema

Interventions

Type	Name	Description
DEVICE	Zephyr Endobronchial Valve (EBV)	• Implantation of at least one Zephyr EBV following Chartis assessment

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2012-04-18
• Last updated: 2017-12-26

Locations

1 site across 1 country: Germany