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

Use of the Chartis® Assessment System prior to EBV Treatment

Study Overview

• Status: Completed
• Conditions: Emphysema
• Intervention / Treatment: Device: Chartis System; Device: Endobronchial Valve (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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69126
    • University of Heidelberg
• Netherlands
  • Groningen, Netherlands
    • UMC Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Chartis System-EBV Treatment; 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lung Volume Change	30 Days

Collaborators and Investigators

• Sponsor: Pulmonx Corporation

Publications and helpful links

General Publications

• Herth FJ, Eberhardt R, Gompelmann D, Ficker JH, Wagner M, Ek L, Schmidt B, Slebos DJ. Radiological and clinical outcomes of using Chartis to plan endobronchial valve treatment. Eur Respir J. 2013 Feb;41(2):302-8. doi: 10.1183/09031936.00015312. Epub 2012 May 3.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 12, 2010

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 630-0011