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

This study has been terminated.
Sponsor:
Information provided by:
Emphasys Medical
ClinicalTrials.gov Identifier:
NCT00137956
First received: August 26, 2005
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Emphysema
Chronic Obstructive Pulmonary Disease
Device: Emphasys Endobronchial Valve (EBV) Device and Procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study

Resource links provided by NLM:


Further study details as provided by Emphasys Medical:

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

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

Estimated Enrollment: 270
Study Start Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137956

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

Publications:

ClinicalTrials.gov Identifier: NCT00137956     History of Changes
Other Study ID Numbers: 630-0005
Study First Received: August 26, 2005
Last Updated: August 14, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Emphasys Medical:
Endobronchial Valve
Endobronchial Valve ProcedureEBV
EBV Procedure
Endobronchial Lung Volume Reduction
Lung Volume Reduction

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014