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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00684892

Enrollment

Registered

2008-05-28

Start date

2008-05-31

Completion date

2008-11-30

Last updated

2009-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heterogeneous Emphysema

Keywords

Emphysema, Endobronchial Lung Volume Reduction

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).

Interventions

DEVICEChartis System

Assessment of airway flow and pressure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse events	Until end of study procedure

Secondary

Measure	Time frame
Technical success	During procedure and up 1 week post procedure

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026