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NCT00684684 Clinical Trial

Safety and Feasibility Study of the Chartis System

Bronchoscopy Clinical Trial

Official title:
A Safety and Feasibility Study of the Chartis System During Diagnostic Bronchoscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00684684
Other study ID # PRT01028
Secondary ID
Status Completed
Phase Phase 1
First received May 23, 2008
Last updated January 20, 2009
Start date May 2008
Est. completion date November 2008

Study information
Verified date January 2009
Source Pulmonx, Inc.
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Chartis System
Assessment of airway flow and pressure

Locations
Country Name City State
Germany Thoraxklinik am Universitatsklinikum Heidelberg Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Pulmonx, Inc.

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events Until discharge or 24 hours post procedure Yes
Secondary Technical success During procedure No
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