[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562010":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":78,"collaborators":80,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":26,"enrollmentInfo":95,"targetDuration":26,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":112,"whyStopped":26,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Hopitaux Prives de Metz, Groupe UNEOS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","Thoracic Surgeons will apply the experimental device TenaTac® after major lung resection",[13],"Device: Intraoperative use of TenaTac in lung surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Thoracic Surgeons will apply other (usual) sealing device after major lung resection",[19],"Device: Intraoperative use of usual sealant in lung surgery",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Intraoperative use of TenaTac in lung surgery","Use of innovative medical device : TenaTac",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Intraoperative use of usual sealant in lung surgery","Use of the usual scealant as a control",[15],[32],{"name":33,"affiliation":34,"role":35},"Alessandro ORSINI, MD","Hôpitaux Privés de Metz, Groupe UNEOS","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Sofiane Saada, PhD","CONTACT","+33357843376","+33","sofiane.saada@uneos.fr",{"name":33,"role":39,"phone":44,"phoneExt":41,"email":45},"+33357842227","alessandro.orsini@uneos.fr",[47,63],{"facility":48,"status":26,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Hôpital Robert Schuman_Groupe UNEOS","Metz","Grand Est","57000","France","FR",{"type":55,"coordinates":56},"Point",[57,58],6.17269,49.11911,{"lat":58,"lon":57},[61,62],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":64,"status":26,"city":65,"state":26,"zip":66,"country":52,"countryCode":53,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Centre Hospitalier de la Côte Basque (Bayonne)","Bayonne","64100",{"type":55,"coordinates":68},[69,70],-1.473,43.49316,{"lat":70,"lon":69},[73,77],{"name":74,"role":39,"phone":75,"phoneExt":41,"email":76},"Caroline RIVERA, MD","+33559443502","crivera@ch-cotebasque.fr",{"name":74,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":79,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[81,84],{"name":82,"class":83},"CuraMedrix B.V.","UNKNOWN",{"name":85,"class":83},"Medical Advices Consulting","100562010","evaluation-of-the-effectiveness-and-security-of-tenatac-in-the-prevention-of-air-leaks-in-thoracic-surgery-100562010",false,"NCT06597604","Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery","TENATAC","Inclusion Criteria:\n\n* Patients hospitalized in the thoracic surgery departments of the investigating centers, for elective surgery,\n* Lobectomy surgery requiring the use of a sealing agent,\n* Adult patients (\\>18 years),\n* Patients who have given written consent to participate in the study,\n* Patients registered within the social security insurance in France.\n\nExclusion Criteria:\n\n* Patients hospitalized in emergency,\n* Patients with gelatin allergy,\n* Patients undergoing other biomedical research likely to interfere with the evaluation criteria of this study\n* Patients under tutorship and\u002For curatorship,\n* Patients unable to follow the planned post-operative follow-up,\n* Patients whose life expectancy is less than 1 year,\n* Pregnant or breast-feeding patients.","ALL","18 Years",{"count":96,"type":97},154,"ESTIMATED","INTERVENTIONAL",[100],"NA","Lung surgery remains a high-risk procedure, with serious adverse events that can occur later, including postoperative bleeding or hemothorax, pneumopathy or surgical site infection but also ... per- and post-operative air leaks. Majority the air leaks resolve spontaneously within 48 hours but certain cases persist within several days which known as prolonged air leaks, or PAL. Several safe and effective sealing agents are used to contain and or reduce the intensity and incidence of postoperative air leaks, and the time required for drain removal. This protocol assesses the effectiveness of an innovative gelatin-based medical device named TenaTac® (Selentus Science, UK) in preventing air leak after major lung resection.",[103],"Lung Surgery",[105,106,107,108,109,110,111],"Lung surgery","TenaTac","Gelatin Patch","Sealant","PAL","Pulmonary Air Leak","Lobectomy","NOT_YET_RECRUITING","2025-01-30",{"date":115,"type":116},"2025-02-03","ACTUAL",{"date":118,"type":97},"2025-03-01",{"date":120,"type":97},"2026-06-30",{"name":5,"class":6},2]