NCT01101958

A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR)

A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR) in Subjects With Heterogeneous Emphysema

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Pulmonx Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Use of the Chartis® Assessment System prior to EBV Treatment

Detailed description

This is a multi-center study which will enroll up to 120 patients. Subjects will undergo a Chartis Assessment prior to EBV treatment. The Chartis assessment will determine the presence or absence of collateral ventilation, a potential determining factor in the success of EBV therapy. This study is not randomized; all subjects are eligible to receive EBV Treatment, regardless of Chartis Assessment outcome. Follow-up data will only be collected on those patients that meet the Chartis inclusion criteria.

Conditions

• Emphysema

Interventions

Type	Name	Description
DEVICE	Chartis System	The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways.
DEVICE	Endobronchial Valve (EBV) Treatment	The endobronchial valve is designed to induce target lobe volume reduction.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-04-12
• Last updated: 2017-05-12
• Results posted: 2014-01-23

Locations

2 sites across 2 countries: Germany, Netherlands