Back to resultsA Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR)
Primary Purpose
Emphysema
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Chartis System
Endobronchial Valve (EBV) Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Emphysema
Eligibility Criteria
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.
Sites / Locations
- University of Heidelberg
- UMC Groningen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Chartis System-EBV Treatment
Arm 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).
Outcomes
Primary Outcome Measures
Lung Volume Change
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01101958
Brief Title
A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR)
Official Title
A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR) in Subjects With Heterogeneous Emphysema
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmonx Corporation
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chartis System-EBV Treatment
Arm Type
Other
Arm 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).
Intervention Type
Device
Intervention Name(s)
Chartis System
Intervention Description
The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways.
Intervention Type
Device
Intervention Name(s)
Endobronchial Valve (EBV) Treatment
Intervention Description
The endobronchial valve is designed to induce target lobe volume reduction.
Primary Outcome Measure Information:
Title
Lung Volume Change
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
UMC Groningen
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
22556025
Citation
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.
Results Reference
derived
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A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR)
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