Safety and Feasibility Study of the Chartis System

This study is currently recruiting participants.

Verified by Pulmonx, Inc., May 2008

Sponsored by:	Pulmonx, Inc.
Information provided by:	Pulmonx, Inc.
ClinicalTrials.gov Identifier:	NCT00684684

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Safety Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Technical success [ Time Frame: During procedure ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	May 2008
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: Chartis System Assessment of airway flow and pressure

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684684

Contacts

Contact: Felix Herth, MD	49-62-21-396-1200	felix.herth@thoraxklinik-heidelberg.de
Contact: Ralf Eberhardt, MD	49-62-21-396-1204	ralf.eberhardt@thoraxklinik-heidelberg.de

Locations

Germany
Thoraxklinik am Universitatsklinikum Heidelberg	Recruiting
Heidelberg, Germany, D-69126
Contact: Felix Herth, MD 49-62-21-396-1200 felix.herth@thoraxklinik-heidelberg.de
Principal Investigator: Felix Herth, MD

Sponsors and Collaborators

Pulmonx, Inc.

Investigators

Principal Investigator:

Felix Herth, MD

Thoraxklinik am Universitatsklinikum Heidelberg

More Information

Responsible Party:	Pulmonx, Inc. ( Carol Anne Yarbrough, RN, Director, Clinical Affairs )
Study ID Numbers:	PRT01028
Study First Received:	May 23, 2008
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00684684
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pulmonx, Inc.:

Bronchoscopy
Clinically indicated for routine diagnostic bronchoscopy

ClinicalTrials.gov processed this record on January 16, 2009