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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00137956
• Other study ID #: 630-0005
• Status: Terminated
• Phase: Phase 3
• First received: August 26, 2005
• Last updated: August 14, 2009
• Start date: December 2004

Study information

• Verified date: August 2009
• Source: Emphasys Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 270
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Device:
• Emphasys Endobronchial Valve (EBV) Device and Procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Emphasys Medical

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days
Secondary	The cost-effectiveness ratio in the treatment group of the study will be compared to established therapies and standards.