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

This study has been completed.
Sponsor:
Information provided by:
Pulmonx, Inc.
ClinicalTrials.gov Identifier:
NCT00684892
First received: May 23, 2008
Last updated: January 20, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Heterogeneous Emphysema
Device: Chartis System
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Pulmonx, Inc.:

Primary Outcome Measures:
  • Adverse events [ Time Frame: Until end of study procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Technical success [ Time Frame: During procedure and up 1 week post procedure ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: May 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Chartis System
Assessment of airway flow and pressure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Carol Anne Yarbrough, RN, Director, Clinical Affairs, Pulmonx, Inc.
ClinicalTrials.gov Identifier: NCT00684892     History of Changes
Other Study ID Numbers: PRT01029
Study First Received: May 23, 2008
Last Updated: January 20, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 18, 2014