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Safety and Feasibility Study of the Chartis System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00684684
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : January 22, 2009
Information provided by:
Pulmonx, Inc.

May 23, 2008
May 28, 2008
January 22, 2009
May 2008
November 2008   (Final data collection date for primary outcome measure)
Adverse events [ Time Frame: Until discharge or 24 hours post procedure ]
Same as current
Complete list of historical versions of study NCT00684684 on ClinicalTrials.gov Archive Site
Technical success [ Time Frame: During procedure ]
Same as current
Not Provided
Not Provided
Safety and Feasibility Study of the Chartis System
A Safety and Feasibility Study of the Chartis System During Diagnostic Bronchoscopy
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 during bronchoscopy.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Device: Chartis System
Assessment of airway flow and pressure
Experimental: 1
Intervention: Device: Chartis System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2008
November 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scheduled to undergo clinically indicated routine diagnostic bronchoscopy

Exclusion Criteria:

  • Hyperexcretive chronic bronchitis or excessive sputum secretion
  • Active pulmonary infection
  • FEV1 <20% predicted
  • FVC <50% predicted
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Carol Anne Yarbrough, RN, Director, Clinical Affairs, Pulmonx, Inc.
Pulmonx, Inc.
Not Provided
Principal Investigator: Felix Herth, MD Thoraxklinik am Universitatsklinikum Heidelberg
Pulmonx, Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP