Safety and Feasibility Study of the Chartis System

This study has been completed.
Sponsor:
Information provided by:
Pulmonx, Inc.
ClinicalTrials.gov Identifier:
NCT00684684
First received: May 23, 2008
Last updated: January 20, 2009
Last verified: January 2009

May 23, 2008
January 20, 2009
May 2008
November 2008   (final data collection date for primary outcome measure)
Adverse events [ Time Frame: Until discharge or 24 hours post procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00684684 on ClinicalTrials.gov Archive Site
Technical success [ Time Frame: During procedure ] [ Designated as safety issue: No ]
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
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Bronchoscopy
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.
 
Completed
18
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00684684
PRT01028
No
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