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

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ClinicalTrials.gov Identifier: NCT00684892
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : January 22, 2009
Sponsor:
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Heterogeneous Emphysema Device: Chartis System Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Safety and Feasibility Study of the Chartis System in Subjects With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
Study Start Date : May 2008
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Device: Chartis System
Assessment of airway flow and pressure


Outcome Measures

Primary Outcome Measures :
  1. Adverse events [ Time Frame: Until end of study procedure ]

Secondary Outcome Measures :
  1. Technical success [ Time Frame: During procedure and up 1 week post procedure ]

Eligibility Criteria

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:   No
Criteria

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
Contacts and Locations

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): NCT00684892


Locations
Germany
Thoraxklinik am Universitatsklinikum Heidelberg
Heidelberg, Germany, D-69126
Sponsors and Collaborators
Pulmonx, Inc.
Investigators
Principal Investigator: Felix Herth, MD Thoraxklinik am Universitatsklinikum Heidelberg
More Information

Responsible Party: Carol Anne Yarbrough, RN, Director, Clinical Affairs, Pulmonx, Inc.
ClinicalTrials.gov Identifier: NCT00684892     History of Changes
Other Study ID Numbers: PRT01029
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009

Keywords provided by Pulmonx, Inc.:
Emphysema
Endobronchial Lung Volume Reduction

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