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

This study has been completed.
Information provided by (Responsible Party):
Pulmonx, Inc. Identifier:
First received: April 8, 2010
Last updated: April 6, 2017
Last verified: April 2017
Use of the Chartis® Assessment System prior to EBV Treatment

Condition Intervention
Emphysema Device: Chartis System Device: Endobronchial Valve (EBV) Treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR) in Subjects With Heterogeneous Emphysema

Resource links provided by NLM:

Further study details as provided by Pulmonx, Inc.:

Primary Outcome Measures:
  • Lung Volume Change [ Time Frame: 30 Days ]

Enrollment: 96
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Chartis System-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).
Device: Chartis System
The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways.
Device: Endobronchial Valve (EBV) Treatment
The endobronchial valve is designed to induce target lobe volume reduction.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01101958

University of Heidelberg
Heidelberg, Germany, 69126
UMC Groningen
Groningen, Netherlands
Sponsors and Collaborators
Pulmonx, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pulmonx, Inc. Identifier: NCT01101958     History of Changes
Other Study ID Numbers: 630-0011
Study First Received: April 8, 2010
Results First Received: December 4, 2013
Last Updated: April 6, 2017

Additional relevant MeSH terms:
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases processed this record on August 18, 2017