Heterogeneous Emphysema Clinical Trial
Official title:
A Safety and Feasibility Study of the Chartis System in Subjects With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
Verified date | January 2009 |
Source | Pulmonx, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).
Status | Completed |
Enrollment | 25 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Heterogeneous emphysema as determined by high-resolution CT scan - Scheduled for clinically indicated ELVR procedure Exclusion Criteria: - Hyperexcretive chronic bronchitis or excessive sputum secretion - Active pulmonary infection - Active asthma or lung hyper-responsiveness |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Germany | Thoraxklinik am Universitatsklinikum Heidelberg | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
Pulmonx, Inc. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | Until end of study procedure | Yes | |
Secondary | Technical success | During procedure and up 1 week post procedure | No |
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