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Use of the Chartis® Assessment System prior to EBV Treatment
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chartis System-EBV Treatment | Other | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chartis System | Device | The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lung Volume Change | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Heidelberg | Heidelberg | 69126 | Germany | |||
| UMC Groningen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22556025 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm--CV Negative | This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System. |
| FG001 | Treatment Arm--CV Positive | This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm--CV Negative | This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System. |
| BG001 | Treatment Arm--CV Positive |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lung Volume Change | Per protocol population analyzed [16 subjects have been excluded due to the following reasons: lacked HRCT(n=6), Lost to Follow-Up (n=8) or died (n=2) of unrelated causes]. | Posted | Median | Inter-Quartile Range | percent decrease in lung volume | 30 Days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm--CV Negative | This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. F.J.F. Herth | ThoraxKlinik, University of Heidelberg | 650-216-0176 | Felix.Herth@thoraxklinik-heidelberg.de |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Endobronchial Valve (EBV) Treatment | Device | The endobronchial valve is designed to induce target lobe volume reduction. |
|
| Groningen |
| Netherlands |
This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 6 |
| 51 |
| 0 |
| 51 |
| EG001 | Treatment Arm--CV Positive | This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System. | 5 | 29 | 0 | 29 |
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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