Back to resultsSafety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
Primary Purpose
Heterogeneous Emphysema
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Chartis System
Sponsored by
About this trial
This is an interventional diagnostic trial for Heterogeneous Emphysema focused on measuring Emphysema, Endobronchial Lung Volume Reduction
Eligibility Criteria
Inclusion Criteria:
- Heterogeneous emphysema as determined by high-resolution CT scan
- Scheduled for clinically indicated ELVR procedure
Exclusion Criteria:
- Hyperexcretive chronic bronchitis or excessive sputum secretion
- Active pulmonary infection
- Active asthma or lung hyper-responsiveness
Sites / Locations
- Thoraxklinik am Universitatsklinikum Heidelberg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
Technical success
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00684892
Brief Title
Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
Official Title
A Safety and Feasibility Study of the Chartis System in Subjects With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pulmonx Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and feasibility of the Chartis System in measuring air flow and pressures in isolated lung compartments in emphysema patients prior to endobronchial lung volume reduction (ELVR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heterogeneous Emphysema
Keywords
Emphysema, Endobronchial Lung Volume Reduction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Chartis System
Intervention Description
Assessment of airway flow and pressure
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
Until end of study procedure
Secondary Outcome Measure Information:
Title
Technical success
Time Frame
During procedure and up 1 week post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Heterogeneous emphysema as determined by high-resolution CT scan
Scheduled for clinically indicated ELVR procedure
Exclusion Criteria:
Hyperexcretive chronic bronchitis or excessive sputum secretion
Active pulmonary infection
Active asthma or lung hyper-responsiveness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Herth, MD
Organizational Affiliation
Thoraxklinik am Universitatsklinikum Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoraxklinik am Universitatsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69126
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Feasibility Study of the Chartis System With Heterogeneous Emphysema Prior to Endobronchial Lung Volume Reduction (ELVR)
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