A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR)

Not Applicable

Completed

• Conditions: Emphysema
• Interventions: Device: Chartis System; Device: Endobronchial Valve (EBV) Treatment

• Registration Number: NCT01101958
• Lead Sponsor: Pulmonx Corporation

Brief Summary

Use of the Chartis® Assessment System prior to EBV Treatment

Detailed Description

This is a multi-center study which will enroll up to 120 patients. Subjects will undergo a Chartis Assessment prior to EBV treatment. The Chartis assessment will determine the presence or absence of collateral ventilation, a potential determining factor in the success of EBV therapy. This study is not randomized; all subjects are eligible to receive EBV Treatment, regardless of Chartis Assessment outcome. Follow-up data will only be collected on those patients that meet the Chartis inclusion criteria.

Study Timeline

• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-12
• Study Start: 2012-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2013-12-04
• Results First Submitted QC: 2013-12-04
• Results First Posted: 2014-01-23
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Heterogeneous emphysema
• Able to obtain a Chartis value during Assessment

Exclusion Criteria

• Any co-existing major medical problems that would not make it possible for the subject to tolerate a bronchoscopic procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chartis System-EBV Treatment	Chartis System	Subjects with heterogeneous emphysema, had their collateral ventilation status in the target treatment lobe assessed using the Chartis System (CV- or CV+) and underwent endobronchial lung volume reduction (ELVR) with endobronchial valves (EBV).
Chartis System-EBV Treatment	Endobronchial Valve (EBV) Treatment	Subjects with heterogeneous emphysema, had their collateral ventilation status in the target treatment lobe assessed using the Chartis System (CV- or CV+) and underwent endobronchial lung volume reduction (ELVR) with endobronchial valves (EBV).

Primary Outcome Measures

Name	Time	Method
Lung Volume Change	30 Days

Trial Locations

Locations (2)

University of Heidelberg; 🇩🇪 Heidelberg, Germany

UMC Groningen; 🇳🇱 Groningen, Netherlands