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Safety and Feasibility Study of the Chartis System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00684684
First Posted: May 28, 2008
Last Update Posted: January 22, 2009
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.
Information provided by:
Pulmonx, Inc.
  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 during bronchoscopy.

Condition Intervention Phase
Bronchoscopy Device: Chartis System Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Safety and Feasibility Study of the Chartis System During Diagnostic Bronchoscopy

Further study details as provided by Pulmonx, Inc.:

Primary Outcome Measures:
  • Adverse events [ Time Frame: Until discharge or 24 hours post procedure ]

Secondary Outcome Measures:
  • Technical success [ Time Frame: During procedure ]

Enrollment: 18
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT00684684


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: NCT00684684     History of Changes
Other Study ID Numbers: PRT01028
First Submitted: May 23, 2008
First Posted: May 28, 2008
Last Update Posted: January 22, 2009
Last Verified: January 2009

Keywords provided by Pulmonx, Inc.:
Bronchoscopy
Clinically indicated for routine diagnostic bronchoscopy