Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684892
• Other study ID #: PRT01029
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 23, 2008
• Last updated: January 20, 2009
• Start date: May 2008
• Est. completion date: November 2008

Study information

• 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

Clinical Trial Summary

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).

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Emphysema
• Heterogeneous Emphysema
• Pulmonary Emphysema

Intervention

Device:
• Chartis System
Assessment of airway flow and pressure

Locations

Country	Name	City	State
Germany	Thoraxklinik am Universitatsklinikum Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Pulmonx, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

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