Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)

Pulmonx

Status and phase: Completed; Phase 2; Phase 1

Conditions: Heterogeneous Emphysema

Treatments: Device: Chartis System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00684892

PRT01029

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 in emphysema patients prior to endobronchial lung volume reduction (ELVR).

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heterogeneous emphysema as determined by high-resolution CT scan
• Scheduled for clinically indicated ELVR procedure

Exclusion criteria

• Hyperexcretive chronic bronchitis or excessive sputum secretion
• Active pulmonary infection
• Active asthma or lung hyper-responsiveness

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

1

Experimental group

Treatment:

Device: Chartis System