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

NCT ID: NCT00137956

Last Updated: 2009-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Emphasys Endobronchial Valve (EBV) Device and Procedure

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emphasys Medical

INDUSTRY

Sponsor Role: lead

Principal Investigators

Robert Kaplan, PhD

Role: PRINCIPAL_INVESTIGATOR

UCLA School of Public Health, UCSD Health Outcomes Assessment Program (HOAP)

References

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Other Identifiers

630-0005

Identifier Type: -

Identifier Source: org_study_id