Safety and Feasibility Study of the Chartis System

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00684684

Enrollment

Registered

2008-05-28

Start date

2008-05-31

Completion date

2008-11-30

Last updated

2009-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoscopy

Keywords

Bronchoscopy, Clinically indicated for routine diagnostic bronchoscopy

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.

Interventions

DEVICEChartis System

Assessment of airway flow and pressure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse events	Until discharge or 24 hours post procedure

Secondary

Measure	Time frame
Technical success	During procedure

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026