Skip to main content
OpenTrials
Completed

NCT Number: NCT01101958

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

Use of the Chartis® Assessment System prior to EBV Treatment

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Emphysema Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Heidelberg, Heidelberg, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Chartis System

Device

The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways.

Endobronchial Valve (EBV) Treatment

Device

The endobronchial valve is designed to induce target lobe volume reduction.

Primary outcomes

  1. Lung Volume Change

    Time frame: 30 Days

Sponsors and collaborators

Lead sponsor

Pulmonx Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 12, 2010
Registry last updated
May 12, 2017

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.

Related clinical trials

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