[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530021":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":38,"responsibleParty":281,"collaborators":11,"id":283,"slug":284,"hasResults":285,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":285,"sex":291,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":11,"studyType":297,"phases":298,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":317},{"fullName":5,"class":6},"University Hospital, Limoges","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"two-stage ZEPHYR® valves","EXPERIMENTAL",null,[13],"Procedure: Endoscopic lung volume reduction in 2 stages",{"label":15,"type":16,"description":11,"interventionNames":17},"one-stage ZEPHYR® valves","SHAM_COMPARATOR",[18],"Procedure: Endoscopic lung volume reduction in 1 stage",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"PROCEDURE","Endoscopic lung volume reduction in 2 stages","After the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the experimental group, patients will be treated according to Limoges' treatment algorithm (2 stages)",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Endoscopic lung volume reduction in 1 stage","After the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the control group, the entire lobe will be treated during one procedure",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Thomas EGENOD, MD","CONTACT","05 55 05 68 92","thomas.egenod@chu-limoges.fr",{"name":36,"role":32,"phone":11,"phoneExt":11,"email":37},"Eloise DOBBELS, MD","eloise.dobbels@chu-limoges.fr",[39,58,72,90,104,118,132,146,161,171,185,199,209,223,239,253,267],{"facility":40,"status":41,"city":42,"state":11,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"CHU de Bordeaux","RECRUITING","Bordeaux","33000","France","FR",{"type":47,"coordinates":48},"Point",[49,50],-0.58046,44.84124,{"lat":50,"lon":49},[53,56],{"name":54,"role":32,"phone":11,"phoneExt":11,"email":55},"Maéva ZYSMA, MD","maeva.zysman@chu-bordeaux.fr",{"name":54,"role":57,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":59,"status":41,"city":60,"state":11,"zip":61,"country":44,"countryCode":45,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"CHU de Brest","Brest","29000",{"type":47,"coordinates":63},[64,65],-4.48628,48.39029,{"lat":65,"lon":64},[68,71],{"name":69,"role":32,"phone":11,"phoneExt":11,"email":70},"Christophe GUT-GOBERT, MD","christophe.gut-gobert@chubrest.fr",{"name":69,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":73,"status":74,"city":75,"state":11,"zip":76,"country":44,"countryCode":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Groupe Hospitalier Est - HCL","NOT_YET_RECRUITING","Bron","69500",{"type":47,"coordinates":78},[79,80],4.91303,45.73865,{"lat":80,"lon":79},[83,88],{"name":84,"role":32,"phone":85,"phoneExt":86,"email":87},"François LESTELLE","04 27 85 77 00","+33","francois.lestelle@chu-lyon.fr",{"name":89,"role":57,"phone":11,"phoneExt":11,"email":11},"François LESTELLE, MD",{"facility":91,"status":41,"city":92,"state":11,"zip":93,"country":44,"countryCode":45,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"CHU de Dijon","Dijon","21000",{"type":47,"coordinates":95},[96,97],5.01391,47.31344,{"lat":97,"lon":96},[100,103],{"name":101,"role":32,"phone":11,"phoneExt":11,"email":102},"Nicolas FAVROLT, MD","nicolas.favrolt@chu-dijon.fr",{"name":101,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":105,"status":41,"city":106,"state":11,"zip":107,"country":44,"countryCode":45,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"chu de Grenoble","Grenoble","38000",{"type":47,"coordinates":109},[110,111],5.71479,45.17869,{"lat":111,"lon":110},[114,117],{"name":115,"role":32,"phone":11,"phoneExt":11,"email":116},"amandine BRIAULT, MD","abriault@chu-grenoble.fr",{"name":115,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":119,"status":41,"city":120,"state":11,"zip":121,"country":44,"countryCode":45,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"CHU de Lille","Lille","59000",{"type":47,"coordinates":123},[124,125],3.05512,50.63391,{"lat":125,"lon":124},[128,131],{"name":129,"role":32,"phone":11,"phoneExt":11,"email":130},"Frederic WALLYN, MD","frederic.wallyn@chu-lille.fr",{"name":129,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":133,"status":41,"city":134,"state":11,"zip":135,"country":44,"countryCode":45,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"CHU de Limoges","Limoges","87000",{"type":47,"coordinates":137},[138,139],1.24759,45.83362,{"lat":139,"lon":138},[142,144],{"name":143,"role":32,"phone":11,"phoneExt":11,"email":34},"thomas EGENOD, MD",{"name":145,"role":57,"phone":11,"phoneExt":11,"email":11},"thomas egenod, MD",{"facility":147,"status":41,"city":148,"state":11,"zip":149,"country":44,"countryCode":45,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"APHM","Marseille","13000",{"type":47,"coordinates":151},[152,153],5.38107,43.29695,{"lat":153,"lon":152},[156,159],{"name":157,"role":32,"phone":11,"phoneExt":11,"email":158},"hervé DUTAU, MD","hdutau@ap-hm.fr",{"name":160,"role":57,"phone":11,"phoneExt":11,"email":11},"Hervé DUTAU, MD",{"facility":162,"status":41,"city":148,"state":11,"zip":149,"country":44,"countryCode":45,"cosmosGeoPoint":163,"geoPoint":165,"contacts":166},"Hopital Saint Joseph",{"type":47,"coordinates":164},[152,153],{"lat":153,"lon":152},[167,170],{"name":168,"role":32,"phone":11,"phoneExt":11,"email":169},"Yoann AMMAR, MD","ammar.yoann@gmail.com",{"name":168,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":172,"status":74,"city":173,"state":11,"zip":174,"country":44,"countryCode":45,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"CHU de Nice","Nice","06000",{"type":47,"coordinates":176},[177,178],7.26608,43.70313,{"lat":178,"lon":177},[181,184],{"name":182,"role":32,"phone":11,"phoneExt":11,"email":183},"Jacques BOUTROS, MD","boutros.j@chu-nice.fr",{"name":182,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":186,"status":41,"city":187,"state":11,"zip":188,"country":44,"countryCode":45,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"APHP","Paris","75018",{"type":47,"coordinates":190},[191,192],2.3488,48.85341,{"lat":192,"lon":191},[195,198],{"name":196,"role":32,"phone":11,"phoneExt":11,"email":197},"Armelle MARCEAU, MD","armelle.marceau@bch.aphp",{"name":196,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":186,"status":74,"city":187,"state":11,"zip":200,"country":44,"countryCode":45,"cosmosGeoPoint":201,"geoPoint":203,"contacts":204},"78014",{"type":47,"coordinates":202},[191,192],{"lat":192,"lon":191},[205,208],{"name":206,"role":32,"phone":11,"phoneExt":11,"email":207},"Christine LORUT, MD","christine.lorut@aphp.fr",{"name":206,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":210,"status":74,"city":211,"state":11,"zip":212,"country":44,"countryCode":45,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"CHU de Rouen","Rouen","76000",{"type":47,"coordinates":214},[215,216],1.09932,49.44313,{"lat":216,"lon":215},[219,222],{"name":220,"role":32,"phone":11,"phoneExt":11,"email":221},"Samy LACHKAR, MD","samy.lachkar@churouen.fr",{"name":220,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":224,"status":41,"city":225,"state":11,"zip":226,"country":44,"countryCode":45,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Hopital privé de la loire","Saint-Etienne","42000",{"type":47,"coordinates":228},[229,230],4.39,45.43389,{"lat":230,"lon":229},[233,237],{"name":234,"role":32,"phone":235,"phoneExt":86,"email":236},"Antoine LUCHEZ, MD","04 77 42 27 00","antoine.luchez@gmail.com",{"name":238,"role":57,"phone":11,"phoneExt":11,"email":11},"antoine LUCHEZ, MD",{"facility":240,"status":41,"city":241,"state":11,"zip":242,"country":44,"countryCode":45,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"chu de Strasbourg","Strasbourg","67000",{"type":47,"coordinates":244},[245,246],7.74553,48.58392,{"lat":246,"lon":245},[249,252],{"name":250,"role":32,"phone":11,"phoneExt":11,"email":251},"Romain KESSLER, MD","romain.kessler@chru-strasbourg.fr",{"name":250,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":254,"status":41,"city":255,"state":11,"zip":256,"country":44,"countryCode":45,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Hopital Foch","Suresnes","92150",{"type":47,"coordinates":258},[259,260],2.22929,48.87143,{"lat":260,"lon":259},[263,266],{"name":264,"role":32,"phone":11,"phoneExt":11,"email":265},"Olivier BRUGIERE, MD","o.brugiere@hopitalfoch.com",{"name":264,"role":57,"phone":11,"phoneExt":11,"email":11},{"facility":268,"status":41,"city":269,"state":11,"zip":270,"country":44,"countryCode":45,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"chu de Toulouse","Toulouse","31000",{"type":47,"coordinates":272},[273,274],1.44367,43.60426,{"lat":274,"lon":273},[277,280],{"name":278,"role":32,"phone":11,"phoneExt":11,"email":279},"nicolas GUIBERT, MD","guibert.n@chu-toulouse.fr",{"name":278,"role":57,"phone":11,"phoneExt":11,"email":11},{"type":282,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100530021","trial-evaluating-the-rate-of-pneumothorax-in-severe-emphysema-secondary-to-endoscopic-volume-reduction-with-two-stage-zephyr-valves-versus-endoscopic-volume-reduction-with-one-stage-zephyr-valves-100530021",false,"NCT06181357","Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves","Randomized Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves","REPEAT","Inclusion Criteria:\n\nPatient able to give informed consent and participate in the study\n\n* Age ≥ 35 years old and ≤ 80 years old at the time of signing the consent\n* Emphysema (homogeneous or heterogeneous) on a recent CT scan (\\\u003C 6 months). Heterogeneous emphysema defined by a difference of at least 15% destruction (threshold 910HU) between two adjacent lobes.\n* Destruction ≥ 50% (threshold 910 HU) of the target lobe on the chest scanner\n* Smoking quit for 3 months\n* Dyspnea ≥ 2 according to the modified Medical Research Council (mMRC) questionnaire)\n* Post-bronchodilator FEV between 15 and 50% theoretical\n* Post-bronchodilator total lung capacity ≥ 100% theoretical and post-bronchodilator residual volume ≥ 175% theoretical\n* Distance traveled during the TM6M ≥ 100m\n* Member of or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Asthma considered as main diagnosis\n* Recurrent exacerbations: (\\>3 over the last year or 2 requiring hospitalization)\n* Myocardial infarction or stroke in the 6 months prior to inclusion\n* Symptoms of heart failure in the 6 months prior to inclusion\n* Chest CT abnormalities: giant bulla (occupying more than a third of the pulmonary field), paraseptal emphysema, pulmonary nodule greater than 0.8cm (not applicable pulmonary nodules known for more than a year and stable), fibrosing interstitial pneumonitis, dilated bronchi\n* Pulmonary tomoscintigraphy:\n\n  * Patients for whom the least perfused lobe is not the one with the highest emphysema destruction score\n  * Patients with homogeneous emphysema for whom the perfusion delta (difference in perfusion between the ipsilateral lung and the treated lobe) is less than 10%\n* Arterial blood gas analysis in ambient air: Hypoxemia in ambient air (PaO2 \\\u003C 45 mmHg). Hypercapnia (PaCO2 \\> 55 mmHg)\n* Echocardiography:\n\n  * Left Ventricular Ejection Function \\\u003C 45%\n  * Systolic pulmonary arterial pressure \\> 45 mmHg\n* History of pneumonectomy, lung surgery homolateral to the lobe targeted for endoscopic lung volume reduction\n* History of pneumothorax homolateral to the lobe targeted for endoscopic lung volume reduction\n* History of endoscopic volume reduction\n* Oral corticosteroid therapy \\> 20 mg\u002Fday within the 4 weeks preceding inclusion\n* Symptomatic bronchial dilatations, bronchial colonization with pseudomonas aeruginosa, multi-resistant bacteria or aspergillus origin\n* Metastatic cancer undergoing treatment or whose treatments ended less than 5 years ago\n* Pregnant or breastfeeding women\n* Nickel allergy\n* Patient under guardianship, curatorship or under judicial protection\n* Participation in another interventional clinical research\n* Any other condition which, in the opinion of the investigator, could interfere with the objective of the study or would cause the subject's participation in the study to be suboptimal, in particular (non-exhaustive list) unweaned alcoholism, substance abuse, non-compliance with usual follow-up visits)\n\nsecondary exclusion criteria:\n\n\\- Evidence of collateral ventilation measured by the Chartis system","ALL","35 Years","80 Years",{"count":295,"type":296},244,"ESTIMATED","INTERVENTIONAL",[299],"NA","Chronic obstructive pulmonary disease (COPD) affects 3.5 million people and is the third leading cause of death worldwide. Emphysema involves air retention in the lungs and is ultimately responsible for a major deterioration in the quality of life. Available drug treatments have moderate efficacy whereas surgical lung volume reduction can improve exercise capacity when offered to a very selected population but at the cost of significant morbidity and mortality.\n\nEndoscopic Lung Volume reduction with ZEPHYR® valves improves respiratory function at rest, exercise tolerance and quality of life in patients with little or no interlobar collateral ventilation.\n\nIf this technique has therefore proven its effectiveness, it is not devoid of complications and is notably responsible for pneumothorax in 27% of cases. The management of this complication is clearly codified, ranging from patient monitoring to the removal of one or more valves. It is therefore a subject of major concern for multiple reasons: high incidence, lengthening of hospital stay, increase in the overall cost of care, potential loss of benefit for the patient in the event of permanent withdrawal. valves and above all a potentially fatal event.\n\nA new strategy for implanting ZEPHYR® valves in two stages has been developed in Limoges University Hospital. This innovative algorithm has been evaluated in several non-comparative single or multicenter studies. In those studies, pneumothorax' rate secondary to lung volume reduction with endobronchial valves is rated between 4.5 and 12%. The efficacy of the treatment appears to be comparable with the data found in the trials evaluating in which the entire lobe was treated in one procedure. Moreover, despite two procedures, there does not seem to be any increased risk of occurrence of other complications. Finally, the systematic scheduling of a thoracic computed tomography between the two procedures showed that 26.6% of patients presented a reduction in volume greater than 350mL despite incomplete treatment.\n\nThese data seem promising but no direct comparison with standard one-step treatment has ever been conducted so far.",[302],"COPD",[304,305,306,307,302],"Endobronchial Zephyr® valves","Endoscopic lung volume reduction","Pneumothorax","Emphysema","2026-06-18",{"date":310,"type":311},"2026-06-23","ACTUAL",{"date":313,"type":311},"2024-05-06",{"date":315,"type":296},"2029-06-06",{"name":5,"class":6},17]