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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

August 26, 2005
August 14, 2009
December 2004
Not Provided
The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days
The cost effectiveness ratio in the treatment group as compared to control group at 180 days
Complete list of historical versions of study NCT00137956 on ClinicalTrials.gov Archive Site
The cost-effectiveness ratio in the treatment group of the study will be compared to established therapies and standards.
The cost effectiveness ratio in the treatment group of the study will be compared to established therapies and standards.
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Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study
Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Emphysema
  • Chronic Obstructive Pulmonary Disease
Device: Emphasys Endobronchial Valve (EBV) Device and Procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
270
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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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00137956
630-0005
Not Provided
Not Provided
Emphasys Medical
Not Provided
Principal Investigator: Robert Kaplan, PhD UCLA School of Public Health, UCSD Health Outcomes Assessment Program (HOAP)
Emphasys Medical
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP