Emphysema Clinical Trial
Official title:
Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.
- BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited.
Lung volume reduction surgery is infrequently used because of its high morbi-mortality.
Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA)
treatment has been recently developed and has been shown to be feasible and associated
with an acceptable safety profile, while resulting in improvements in dyspnea, exercise
capacity and lung function. The objective of this study is to analyze the cost
effectiveness of LVRC treatment in severe emphysema.
- METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs
conventional treatment) will include 100 patients who will be followed up for 1year.
The primary outcome measure is the 6-month improvement of the 6-minute walk test: the
percentage of patients showing an improvement of at least 54m will be compared between
groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global
cost of this therapeutic option and will compare the cost between patients treated by
LVRC and by medical treatment alone.
- EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in
severe emphysema. The cost-effectiveness study will assess the medical-economic impact
of the LVRC therapeutic option.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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