Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study
NCT number | NCT00137956 |
Other study ID # | 630-0005 |
Secondary ID | |
Status | Terminated |
Phase | Phase 3 |
First received | August 26, 2005 |
Last updated | August 14, 2009 |
Start date | December 2004 |
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 |
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.
Status | Terminated |
Enrollment | 270 |
Est. completion date | |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Emphasys Medical |
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* Note: There are 25 references in all — Click here to view all references
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. |
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