Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137956
Status:
TERMINATED
Last Update Posted:
2009-08-18
First Post:
2005-08-26
Brief Title:
Endobronchial Valve for Emphysema PalliatioN Trial VENT Cost-effectiveness Sub-Study
Sponsor:
Emphasys Medical
Organization:
Emphasys Medical
Study Overview
Official Title:
Endobronchial Valve for Emphysema PalliatioN Trial VENT Cost-effectiveness Sub-Study
Status:
TERMINATED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 panels 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
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 panels 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None