A Study of the Use of Chartis* System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR) in Subjects with Heterogeneous Emphysema

Phase 2

Completed

• Conditions: COPD Emphysema; 10038716

• Registration Number: NL-OMON34198
• Lead Sponsor: Pulmonx, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

-Heterogeneous emphysema as determined by physician visual review of standard CT
-Able to obtain Chartis measurement value
-Signed informed consent

Exclusion Criteria

-Active pulmonary infection
-FEV1 <15% and > 50% of predicted value
-Any co-existing major medical problems that would not make it possible for the
subject to tolerate a bronchoscopic procedure

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Use of Chartis subject selection algorithm to select subjects most likely to<br /><br>experience a minimum of 350mL volume reduction from EBV treatment, as measured<br /><br>by volumetric CT scan at 30 day follow-up visit.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a</p><br>