Safety and Feasibility Study of the Chartis System

Pulmonx

Status and phase: Completed; Phase 1

Conditions: Bronchoscopy

Treatments: Device: Chartis System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00684684

PRT01028

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

1

Experimental group

Treatment:

Device: Chartis System