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| Name | Class |
|---|---|
| PneumRx, Inc. | INDUSTRY |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung volume reduction coïl treatment | Experimental | Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention |
|
| Regular Medical Treatment | Other | No intervention, just a follow up under usual medical treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung volume reduction coïl treatment | Procedure |
| ||
| Regular medical treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month improvement of the 6-minute walk test | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores. | 6 and 12 months |
| Dyspnea | Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise testing | Comparison of the 6-min walking test between groups (using the > 25 meters change from baseline as cut-off for clinically significant change). | 6 and 12 months months |
| Exercise testing |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaëtan DESLEE, PhD, MD | CHU de Reims | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens | Amiens | 80054 | France | |||
| CHU de Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23200592 | Background | Deslee G, Barbe C, Bourdin A, Durand-Zaleski I, Dutau H, Jolly D, Jounieaux V, Kessler R, Mal H, Pison C, Thiberville L, Vergnon JM, Marquette CH. [Cost-effectiveness of lung volume reduction coil treatment in emphysema. STIC REVOLENS]. Rev Mal Respir. 2012 Nov;29(9):1157-64. doi: 10.1016/j.rmr.2012.09.010. Epub 2012 Oct 12. French. | |
| 30464447 |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Other |
|
| 6 and 12 months |
| Pulmonary function assessment | Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC. | 6 and 12 months |
| Quality of life | Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions) | 6 and 12 months |
| Morbidity-mortality | 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). | 6 and 12 months |
Comparison of the 6-min walking distance at 12 months using 54 meters as cut-off for clinically significant change.
| 12 months |
| Grenoble |
| 38043 |
| France |
| AP-HM | Marseille | 13015 | France |
| CHU de Montpellier | Montpellier | 34295 | France |
| CHU de Nice | Nice | 06002 | France |
| AP-HP - Hôpital Bichat | Paris | 75877 | France |
| CHU de Rouen | Rouen | 76031 | France |
| CHU de Saint-Etienne | Saint-Priest-en-Jarez | 42270 | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
| Perotin JM, Leroy S, Marquette CH, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Barbe C, Deslee G; REVOLENS Study Group. Endobronchial coil treatment in severe emphysema patients with alpha-1 antitrypsin deficiency. Int J Chron Obstruct Pulmon Dis. 2018 Nov 5;13:3645-3649. doi: 10.2147/COPD.S176366. eCollection 2018. |
| 29743071 | Derived | Bulsei J, Leroy S, Perotin JM, Mal H, Marquette CH, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaun M, Marceau A, Dukic S, Barbe C, Bonnaire M, Deslee G, Durand-Zaleski I; REVOLENS study group. Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study). Respir Res. 2018 May 9;19(1):84. doi: 10.1186/s12931-018-0796-x. |
| 29269583 | Derived | Deslee G, Leroy S, Perotin JM, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaun M, Marceau A, Dury S, Benzaquen J, Bonnaire M, Dukic S, Barbe C, Marquette CH; , on behalf of the REVOLENS Study Group13; REVOLENS Study Group. Two-year follow-up after endobronchial coil treatment in emphysema: results from the REVOLENS study. Eur Respir J. 2017 Dec 21;50(6):1701740. doi: 10.1183/13993003.01740-2017. Print 2017 Dec. No abstract available. |
| 26757466 | Derived | Deslee G, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Thiberville L, Leroy S, Marceau A, Laroumagne S, Mallet JP, Dukic S, Barbe C, Bulsei J, Jolly D, Durand-Zaleski I, Marquette CH; REVOLENS Study Group. Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):175-84. doi: 10.1001/jama.2015.17821. |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |