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

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ClinicalTrials.gov Identifier: NCT01101958
Recruitment Status : Completed
First Posted : April 12, 2010
Results First Posted : January 23, 2014
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc.

Brief Summary:
Use of the Chartis® Assessment System prior to EBV Treatment

Condition or disease Intervention/treatment Phase
Emphysema Device: Chartis System Device: Endobronchial Valve (EBV) Treatment Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Arm Intervention/treatment
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.



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


Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101958


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pulmonx, Inc.
ClinicalTrials.gov Identifier: NCT01101958     History of Changes
Other Study ID Numbers: 630-0011
First Posted: April 12, 2010    Key Record Dates
Results First Posted: January 23, 2014
Last Update Posted: May 12, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases