Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study

Study Overview
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Brief Summary
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The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and quality of life information on patients enrolled in the VENT study in order to analyze the relative cost-effectiveness of the endobronchial valve implant procedure.

Detailed Description
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Therapeutic interventions in health care require the use of resources. Since these resources are limited, it is important for clinical decision-makers to have economic information in addition to safety and efficacy data. In the economic environment of health care today, the incremental costs for a new therapeutic intervention must be offset by the value associated with better outcomes such as improved health and health-related quality of life and/or lower health care utilization costs over time. Questions about the cost and effectiveness of medical care have generated considerable attention in medical outcomes research. In 1993, the Department of Health and Human Services appointed a multi-disciplinary group to recommend standards for the evaluation of health care. The panel's report suggested that standardized outcomes analyses be conducted to evaluate the cost-effectiveness of medical care. These analyses require preference-weighted measures of health-related quality of life. Such measures are needed in order to adjust survival time for health-related quality of life.

Official Title
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Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study

Conditions
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Emphysema, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Emphasys Endobronchial Valve (EBV) Device and Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution Forced expiratory volume in 1 second (FEV1) < 45% predicted Total lung capacity (TLC) > 100% predicted Residual volume (RV) > 150% predicted Post rehabilitation 6 minute walk test > 140m Non-smoking for 4 months Exclusion Criteria: Prior lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy or lobectomy History of recurrent respiratory infections Evidence of large bullae (> 30% of either lung) in a non-target lobe FEV1 < 15% predicted Diffusing capacity of the lung for carbon monoxide (DLCO) < 20% predicted

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Emphasys Endobronchial Valve (EBV) Device and Procedure|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost-effectiveness ratio in the treatment group of the study will be compared to established therapies and standards. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endobronchial Valve, Endobronchial Valve ProcedureEBV, EBV Procedure, Endobronchial Lung Volume Reduction, Lung Volume Reduction