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Long Term Follow up Investigation of Endobronchial Valves in Emphysema

NCT ID: NCT01580215

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

628 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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

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Pulmonary Emphysema

Keywords

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Valves Endobronchial Endoscopic lung volume reduction Pulmonx Zephyr Chartis Emphysema COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Main cohort

* 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)

Zephyr Endobronchial Valve (EBV)

Intervention Type DEVICE

• Implantation of at least one Zephyr EBV following Chartis assessment

Interventions

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Zephyr Endobronchial Valve (EBV)

• Implantation of at least one Zephyr EBV following Chartis assessment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pulmonx International Sàrl

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Felix JF Herth, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medizinische Fakultät Heidelberg

Locations

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Heidelberg Hospital

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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630-0013

Identifier Type: -

Identifier Source: org_study_id