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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00137956
Recruitment Status : Terminated
First Posted : August 30, 2005
Last Update Posted : August 18, 2009
Information provided by:
Emphasys Medical

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.

Condition or disease Intervention/treatment Phase
Emphysema Chronic Obstructive Pulmonary Disease Device: Emphasys Endobronchial Valve (EBV) Device and Procedure Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study
Study Start Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Primary Outcome Measures :
  1. The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days

Secondary Outcome Measures :
  1. The cost-effectiveness ratio in the treatment group of the study will be compared to established therapies and standards.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00137956

Sponsors and Collaborators
Emphasys Medical
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Principal Investigator: Robert Kaplan, PhD UCLA School of Public Health, UCSD Health Outcomes Assessment Program (HOAP)

Layout table for additonal information Identifier: NCT00137956    
Other Study ID Numbers: 630-0005
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009
Keywords provided by Emphasys Medical:
Endobronchial Valve
Endobronchial Valve ProcedureEBV
EBV Procedure
Endobronchial Lung Volume Reduction
Lung Volume Reduction
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes