Safety and Feasibility Study of the Chartis System

Phase 1

Completed

• Conditions: Bronchoscopy
• Interventions: Device: Chartis System

• Registration Number: NCT00684684
• Lead Sponsor: Pulmonx Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-20
• Last Update Posted: 2009-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Chartis System	-

Primary Outcome Measures

Name	Time	Method
Adverse events	Until discharge or 24 hours post procedure

Secondary Outcome Measures

Name	Time	Method
Technical success	During procedure

Trial Locations

Locations (1)

Thoraxklinik am Universitatsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany