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

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).

Completed

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Key information

Conditions

Heterogeneous Emphysema Emphysema Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, D-69126, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chartis System

Device

Assessment of airway flow and pressure

Primary outcomes

Adverse events

Time frame: Until end of study procedure

Secondary outcomes

Technical success

Time frame: During procedure and up 1 week post procedure

Sponsors and collaborators

Lead sponsor

Pulmonx Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: May 28, 2008
Registry last updated: Jan 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed