NCT00137956

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (planned)
• Sponsor: Emphasys Medical · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Emphysema
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	Emphasys Endobronchial Valve (EBV) Device and Procedure

Timeline

• Start date: 2004-12-01
• First posted: 2005-08-30
• Last updated: 2009-08-18