[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648866":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":33,"centralContacts":73,"locations":79,"responsibleParty":180,"collaborators":182,"id":186,"slug":187,"hasResults":188,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":188,"sex":194,"minAge":195,"maxAge":33,"enrollmentInfo":196,"targetDuration":33,"studyType":199,"phases":200,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":210,"whyStopped":33,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","After computer-assisted segmentation of the airways and correction of the stenosis VGStudioMAX 3.0) using the CT data, a virtual stent (AnatomikModeling) and mold are designed. The latter is then 3D printed and used for the stent fabrication in silicone (NOVATECH) which is inserted through a rigid bronchoscope.",[13,14,15,16,17,18,19,20,21],"Other: Informed consent","Other: Eligibility criteria check","Other: Randomisation","Behavioral: Dyspnea-12 questionnaire","Behavioral: VQ11 questionnaire","Behavioral: EQ-5D-5L questionnaire","Other: Spirometry","Radiation: Chest CT scan","Procedure: Experimental Stent Implantation",{"label":23,"type":24,"description":25,"interventionNames":26},"Control group","ACTIVE_COMPARATOR","Commercially available stents (NOVATECH) are inserted following the exact same modalities (general anesthesia) and tools (rigid bronchoscope, rigid forceps) than for 3D stents.",[13,14,15,16,17,18,19,20,27],"Procedure: Commercially Stent Implantation",[29,34,38,42,47,51,55,59,64,69],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Informed consent","During the pre-inclusion\u002Finclusion visit, the investigator informs the participant and answers all questions regarding the purpose, nature of the constraints, foreseeable risks and the expected benefits of the clinical investigation. The investigating physician then provides the participant with a copy of the information note and informed consent form. After this information session, the participant is granted a reflection period. If the participant agrees to participate",[23,9],null,{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Eligibility criteria check","The investigator also specifies the participant's rights in the context of research and checks the eligibility criteria.",[23,9],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":33},"Randomisation","When an investigator wishes to perform the randomisation after checking the eligibility criteria and consent of the participant, he\u002Fshe will connect to the dedicated Clinsight Website.",[23,9],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":33},"BEHAVIORAL","Dyspnea-12 questionnaire","The DYSPNEA-12 questionnaire helps to understand how shortness of breath impacts a patient's life. This questionnaire contains 12 questions that assess the physical and emotional aspects of dyspnea in daily life by checking one of the following boxes: not at all, slightly, moderately, severely",[23,9],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":33},"VQ11 questionnaire","The VQ11 questionnaire is a quality of life questionnaire. It contains 11 statements that express feelings about the consequences of a respiratory illness. For each statement, the patient must check the intensity that corresponds to their experience from among: not at all, a little, moderately, a lot, and extremely.",[23,9],{"type":43,"name":52,"description":53,"armGroupLabels":54,"otherNames":33},"EQ-5D-5L questionnaire","This questionnaire assesses the patient's mobility, autonomy, activities, pain, and anxiety using 5 items. For each item, the patient must select the situation that best describes them from among 5 options: no problem, mild problems, moderate problems, severe problems, or unable to function.",[23,9],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":33},"Spirometry","non-invasive measurement of ventilatory function, including peak expiratory flow and forced expiratory volume in 1 second (FEV1)",[23,9],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":33},"RADIATION","Chest CT scan","High resolution chest CT scan without injection of contrast medium. The scanner required for the manufacture of the prosthesis must be a high-resolution CT scanner, the recommendations for which are specified in the order file for a 3D stent",[23,9],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":33},"PROCEDURE","Commercially Stent Implantation","During the commercially stent implantation, a video of the procedure will be recorded and all the pseudonymized videos of each center will be centralized and stored in the pulmonology department of Pr Nicolas Guibert of CHU of Toulouse.",[23],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":33},"Experimental Stent Implantation","During the experimental stent implantation, a video of the procedure will be recorded and all the pseudonymized videos of each center will be centralized and stored in the pulmonology department of Pr Nicolas Guibert of CHU of Toulouse.",[9],[74],{"name":75,"role":76,"phone":77,"phoneExt":33,"email":78},"Audrey TOMASIK","CONTACT","+33 (0) 5 61 77 85 97","tomasik.a@chu-toulouse.fr",[80,102,120,134,152,166],{"facility":81,"status":33,"city":82,"state":33,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Hôpital Marie Lannelongue \u002F Institut Gustave Roussy","Le Plessis-Robinson","92350","France","FR",{"type":87,"coordinates":88},"Point",[89,90],2.27078,48.78889,{"lat":90,"lon":89},[93,98],{"name":94,"role":76,"phone":95,"phoneExt":96,"email":97},"Amir HANNA, Dr","6 46 92 57 71","+33","a.hanna@ghpsj.fr",{"name":99,"role":76,"phone":100,"phoneExt":96,"email":101},"Adrian CRUTU, Dr","1 40 94 25 78","a.crutu@ghpsj.fr",{"facility":103,"status":33,"city":104,"state":33,"zip":105,"country":84,"countryCode":85,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Institut Cœur Poumon - CHU Lille","Lille","59037",{"type":87,"coordinates":107},[108,109],3.05512,50.63391,{"lat":109,"lon":108},[112,116],{"name":113,"role":76,"phone":114,"phoneExt":96,"email":115},"Clément FOURNIER, Dr","3 20 44 44 34","clement.fournier@chu-lille.fr",{"name":117,"role":76,"phone":118,"phoneExt":96,"email":119},"Frédéric WALLYN, Dr","7 86 18 82 45","frederic.wallyn@chu-lille.fr",{"facility":121,"status":33,"city":122,"state":33,"zip":123,"country":84,"countryCode":85,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"CHU Limoges","Limoges","87000",{"type":87,"coordinates":125},[126,127],1.24759,45.83362,{"lat":127,"lon":126},[130],{"name":131,"role":76,"phone":132,"phoneExt":96,"email":133},"Thomas EGENOD, Dr","5 55 05 68 92 60","thomas.egenod@chu-limoges.fr",{"facility":135,"status":33,"city":136,"state":33,"zip":137,"country":84,"countryCode":85,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"CHRU Strasbourg","Strasbourg","67000",{"type":87,"coordinates":139},[140,141],7.74553,48.58392,{"lat":141,"lon":140},[144,148],{"name":145,"role":76,"phone":146,"phoneExt":96,"email":147},"Michele PORZIO, Dr","3 69 55 13 74","michele.porzio@chru-strasbourg.fr",{"name":149,"role":76,"phone":150,"phoneExt":96,"email":151},"Cezar Aurelian MATAU, Dr","3 69 55 07 27","cezaraurelian.matau@chru-strasbourg.fr",{"facility":153,"status":33,"city":154,"state":33,"zip":155,"country":84,"countryCode":85,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Hôpital Foch","Suresnes","92150",{"type":87,"coordinates":157},[158,159],2.22929,48.87143,{"lat":159,"lon":158},[162],{"name":163,"role":76,"phone":164,"phoneExt":96,"email":165},"Daniela USTUROI, Dr","6 45 91 66 63","medic.pneumo@yahoo.com",{"facility":167,"status":33,"city":168,"state":33,"zip":169,"country":84,"countryCode":85,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Larrey Hospital","Toulouse","31059",{"type":87,"coordinates":171},[172,173],1.44367,43.60426,{"lat":173,"lon":172},[176],{"name":177,"role":76,"phone":178,"phoneExt":33,"email":179},"Nicolas GUIBERT, Pr","+33 (0)5 67 77 81 60","guibert.n@chu-toulouse.fr",{"type":181,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[183],{"name":184,"class":185},"novatech","UNKNOWN","100648866","endoscopic-treatment-100648866",false,"NCT07727824","Endoscopic Treatment","Endoscopic Treatment With 3D Customized Versus Standard Stent for Non-malignant Airway Stenoses: A Randomized Controlled Trial","ETNA","Inclusion Criteria:\n\n* Age \\>18 years,\n* Central non-malignant symptomatic (dyspnea \\> grade 2 mMRC or post-stenotic infection) airway stenosis with silicone stent implantation indication (viable downstream airways, pulmonary artery and parenchyma),\n* To have access to a personal telephone for the teleconsultation scheduled in the protocol,\n* Informed consent signed,\n* Health insurance beneficiary.\n\nExclusion Criteria:\n\n* Acute respiratory distress,\n* Mechanical ventilation,\n* Contraindication to rigid bronchoscopy: severe coagulation disorders that cannot be corrected, anticoagulant or antiplatelet therapy other than aspirin within 5 days prior to the stent implantation,\n* Malignant stenosis,\n* Pregnancy or breast-feeding,\n* A situation in which emergency or semi-emergency intervention (less than 48 hours) may be anticipated (like an acute respiratory distress for example),\n* Patient under legal protection, - Participation in another study with an exclusion period still in progress,\n* Impossibility of giving the person informed information and of ensuring the subject's compliance due to impaired physical and\u002For psychological health.","ALL","18 Years",{"count":197,"type":198},96,"ESTIMATED","INTERVENTIONAL",[201],"NA","The placement of an endoprosthesis in the airways leads to rapid and dramatic clinical improvement in the majority of cases of central airway obstruction. However, the limited diversity of device shapes available on the market is a major limitation, as these devices are poorly adapted, or not adapted at all, to the patient's anatomy. The main consequences of this lack of congruity are stent migration and granulomatous inflammatory reactions. The investigators hypothesized that personalized endoprostheses could significantly reduce the complication rate and improve tolerability. In this randomized controlled trial, the investigators propose to evaluate whether personalized endoprostheses allow for better management of non-malignant central airway stenoses by comparing this new approach to standard care.",[204,205],"Stenoses","Dyspnea",[207,190,208,209],"Non-malignant Airway stenoses","3D customized stent","stent","NOT_YET_RECRUITING","2026-07-21",{"date":213,"type":214},"2026-07-27","ACTUAL",{"date":216,"type":198},"2027-01",{"date":218,"type":198},"2031-01",{"name":5,"class":6},6]