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Safety and Feasibility Study of the Chartis System

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ClinicalTrials.gov Identifier: NCT00684684
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : January 22, 2009
Sponsor:
Information provided by:
Pulmonx, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Bronchoscopy Device: Chartis System Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Arm Intervention/treatment
Experimental: 1 Device: Chartis System
Assessment of airway flow and pressure



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

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


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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

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

Responsible Party: Carol Anne Yarbrough, RN, Director, Clinical Affairs, Pulmonx, Inc.
ClinicalTrials.gov Identifier: NCT00684684     History of Changes
Other Study ID Numbers: PRT01028
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009

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