Lung Volume Reduction Coil Treatment in Emphysema.
Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.
ClinicalTrials.gov ID
NCT01822795
Lead Sponsor
CHU de ReimsOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Phase 3
Enrollment
100Estimated
Last Update Posted
Apr 30, 2014Estimated
Start Date
Mar 2013
Primary Completion Date
Mar 2015Estimated
Completion Date
Dec 2019Estimated
Official Title
Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.
Brief Summary
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.
Emphysema
Lung volume reduction coïl treatment
Regular medical treatment
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bilateral emphysema on Chest CT Scanner
Post bronchodilator FEV1 < 50 %
Total Lung Capacity > 100 %
Residual Volume > 220 %
Dyspnea score between 2 and 4 based on the mMRC scale
Stopped cigarette smoking for more than 8 weeks
Pulmonary rehabilitation within the previous twelve months
Consent form signed
Covered by Medical Insurance
Exclusion Criteria:
Post bronchodilator FEV1 < 15%
Post-bronchodilator change in FEV1 > 20%
Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
COPD exacerbation requiring hospital stay within 3 months
Pulmonary Hypertension (Pulmonary systolic pressure >50 mmHg on cardiac echo)
Patient unable to perform a 6-min walking test in room air
Giant bulla of more than 1/3 of the lung field on Chest CT
Strictly homogeneous emphysema on Chest CT
Clinically significant bronchiectasis
Past history of lobectomy, lung volume reduction surgery, lung transplantation
Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…)
Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
Contra-indication to general anesthesia
Oral anticoagulant treatment (antivitamin K)
Allergy to nitinol
Inclusion in an other study assessing respiratory treatments