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

Pulmonx

Status: Completed

Conditions: Emphysema

Treatments: Device: Chartis System; Device: Endobronchial Valve (EBV) Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01101958

630-0011

Details and patient eligibility

About

Use of the Chartis® Assessment System prior to EBV Treatment

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Heterogeneous emphysema
• Able to obtain a Chartis value during Assessment

Exclusion criteria

• Any co-existing major medical problems that would not make it possible for the subject to tolerate a bronchoscopic procedure.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

96 participants in 1 patient group

Chartis System-EBV Treatment

Other group

Description:

Subjects with heterogeneous emphysema, had their collateral ventilation status in the target treatment lobe assessed using the Chartis System (CV- or CV+) and underwent endobronchial lung volume reduction (ELVR) with endobronchial valves (EBV).

Treatment:

Device: Endobronchial Valve (EBV) Treatment

Device: Chartis System