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

Emphasys Medical

Status and phase

Terminated

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Emphysema

Treatments

Device: Emphasys Endobronchial Valve (EBV) Device and Procedure

Study type

Interventional

Funder types

Industry

Identifiers

NCT00137956

630-0005

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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