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

Phase 1

Completed

• Conditions: Heterogeneous Emphysema
• Interventions: Device: Chartis System

• Registration Number: NCT00684892
• Lead Sponsor: Pulmonx Corporation

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-20
• Last Update Posted: 2009-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Chartis System	-

Primary Outcome Measures

Name	Time	Method
Adverse events	Until end of study procedure

Secondary Outcome Measures

Name	Time	Method
Technical success	During procedure and up 1 week post procedure

Trial Locations

Locations (1)

Thoraxklinik am Universitatsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany