A Study of the Use of Chartis Assessment System to Optimize Subject Selection for Endobronchial Lung Volume Reduction.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pulmonx, Inc.
ClinicalTrials.gov Identifier:
NCT01101958
First received: April 8, 2010
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

Use of the Chartis® Assessment System prior to EBV Treatment


Condition Intervention
Emphysema
Device: Chartis Assessment System with Endobronchial Valve

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Pulmonx, Inc.:

Primary Outcome Measures:
  • Lung Volume Reduction [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

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
Active Comparator: Chartis Assessment with Endobronchial Valve (CV negative)
This arm had emphysema and during bronchoscopy was determined to have minimal or no collateral ventilation in the target treatmetn lobe as measured using the Chartis Pulmonary Assessment System.
Device: Chartis Assessment System with Endobronchial Valve
The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways. The endobronchial valve is designed to induce target lobe volume reduction.
Active Comparator: Chartis Assessment with Endobronchial Valve (CV positive)
This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
Device: Chartis Assessment System with Endobronchial Valve
The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT01101958

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

No publications provided by Pulmonx, Inc.

Additional 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
Study First Received: April 8, 2010
Results First Received: December 4, 2013
Last Updated: December 4, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 09, 2014