Lung Volume Reduction Coil Treatment in Emphysema. (STICREVOLENS)
This study is currently recruiting participants.
Verified April 2013 by CHU de Reims
CHU de Reims
Information provided by (Responsible Party):
CHU de Reims
First received: March 28, 2013
Last updated: April 3, 2013
Last verified: April 2013
- 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.
Procedure: Lung volume reduction coïl treatment
Other: Regular medical treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.|
Resource links provided by NLM:
Further study details as provided by CHU de Reims:
Primary Outcome Measures:
- 6-month improvement of the 6-minute walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Cost-effectiveness [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.
- Dyspnea [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale
- Pulmonary function assessment [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.
- Quality of life [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)
- Morbidity-mortality [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]Comparison of mortality and severe adverse events using a composite score (death, haemoptysis > 150 cc, pneumonia requiring hospitalization, pneumothorax requiring chest tube drainage > 7 days, mechanical ventilation > 24 hours, lung transplantation).
Other Outcome Measures:
- Exercise testing [ Time Frame: 6 and 12 months months ] [ Designated as safety issue: No ]Comparison of the 6-min walking test between groups (using the > 25 meters change from baseline as cut-off for clinically significant change).
- Exercise testing [ Time Frame: 12 months ] [ Designated as safety issue: No ]Comparison of the 6-min walking distance at 12 months using 54 meters as cut-off for clinically significant change.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Lung volume reduction coïl treatment
Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention
|Procedure: Lung volume reduction coïl treatment Other: Regular medical treatment|
Regular Medical Treatment
No intervention, just a follow up under usual medical treatment
|Other: Regular medical treatment|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822795
|Contact: Gaëtan DESLEE, PhD, MD||326787611 ext email@example.com|
|Contact: Margaux VERDIER||326787767 ext firstname.lastname@example.org|
|AMIENS Cedex 1, France, 80054|
|Principal Investigator: Vincent JOUNIEAUX, PhD, MD|
|CHU de Grenoble||Recruiting|
|GRENOBLE Cedex 9, France, 38043|
|Principal Investigator: Christophe PISON, PhD, MD|
|Marseille, France, 13015|
|Principal Investigator: Hervé DUTAU, MD|
|CHU de Montpellier||Recruiting|
|MONTPELLIER Cedex 5, France, 34295|
|Principal Investigator: Arnaud BOURDIN, PhD, MD|
|CHU de Nice||Recruiting|
|Nice, France, 06002|
|Principal Investigator: Charles-Hugo MARQUETTE, PhD, MD|
|AP-HP - Hôpital Bichat||Recruiting|
|PARIS Cedex 18, France, 75877|
|Principal Investigator: Hevé MAL, PhD, MD|
|CHU de Rouen||Recruiting|
|ROUEN Cedex, France, 76031|
|Principal Investigator: Luc THIBERVILLE, PhD, MD|
|CHU de Saint-Etienne||Recruiting|
|Saint-priest-en-jarez, France, 42270|
|Principal Investigator: Jean-Michel VERGNON, PhD, MD|
|Hôpitaux Universitaires de Strasbourg||Recruiting|
|STRASBOURG Cedex, France, 67091|
|Principal Investigator: Romain KESSLER, PhD, MD|
Sponsors and Collaborators
CHU de Reims
|Principal Investigator:||Gaëtan DESLEE, PhD, MD||CHU de Reims|