A Study of the Use of Chartis Assessment System to Optimize Subject Selection for Endobronchial Lung Volume Reduction.

Emphysema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101958
• Other study ID #: 630-0011
• Status: Completed
• Phase: N/A
• First received: April 8, 2010
• Last updated: December 4, 2013
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2013
• Source: Pulmonx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Use of the Chartis® Assessment System prior to EBV Treatment

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema

Intervention

Device:
• Chartis Assessment System with Endobronchial Valve
The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways. The endobronchial valve is designed to induce target lobe volume reduction.

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg
Netherlands	UMC Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Pulmonx, Inc.

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Volume Reduction		30 Days	No