[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436800":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":42,"responsibleParty":127,"collaborators":26,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":26,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":26,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":151,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Breast Reconstruction with breast mesh","EXPERIMENTAL","The tissue expander-implant reconstruction with TiLoop Bra mesh.",[13],"Procedure: TiLoop Bra mesh in expander-implant breast reconstrution",{"label":15,"type":16,"description":17,"interventionNames":18},"Breast Reconstruction without breast mesh","ACTIVE_COMPARATOR","The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle\u002Ffascia.",[19],"Procedure: sub-pectoral expander-implant breast reconstruction",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","TiLoop Bra mesh in expander-implant breast reconstrution","The tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple\u002Fskin-sparing mastectomy. The tissue expander is placed sub-pectoral.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"sub-pectoral expander-implant breast reconstruction","The tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple\u002Fskin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle\u002Ffascia.",[15],[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Jian Yin","CONTACT","+86-22-23340123","1174","yinjian@tjmuch.com",{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},"Bowen Ding","1171","ding_x87@126.com",[43,60,74,86,102,114],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-95.36327,29.76328,{"lat":55,"lon":54},[58],{"name":59,"role":34,"phone":26,"phoneExt":26,"email":26},"Edward Chang",{"facility":61,"status":45,"city":62,"state":63,"zip":26,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Gansu Provincial Cancer Hospital","Lanzhou","Gansu","China","CN",{"type":52,"coordinates":67},[68,69],103.83987,36.05701,{"lat":69,"lon":68},[72],{"name":73,"role":34,"phone":26,"phoneExt":26,"email":26},"Suisheng Yang",{"facility":75,"status":45,"city":76,"state":77,"zip":26,"country":64,"countryCode":65,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Jilin Cancer Hospital","Ch’ang-ch’un","Jilin",{"type":52,"coordinates":79},[80,81],126.24667,42.74694,{"lat":81,"lon":80},[84],{"name":85,"role":34,"phone":26,"phoneExt":26,"email":26},"Guiying Xu",{"facility":5,"status":45,"city":87,"state":88,"zip":89,"country":64,"countryCode":65,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Tianjin","Tianjin Municipality","300060",{"type":52,"coordinates":91},[92,93],117.17667,39.14222,{"lat":93,"lon":92},[96,98,100],{"name":39,"role":34,"phone":97,"phoneExt":26,"email":41},"18822077799",{"name":33,"role":99,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":39,"role":101,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"facility":103,"status":45,"city":104,"state":105,"zip":26,"country":64,"countryCode":65,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Zhejiang Provincial People's Hospital","Hangzhou","Zhejiang",{"type":52,"coordinates":107},[108,109],120.16142,30.29365,{"lat":109,"lon":108},[112],{"name":113,"role":34,"phone":26,"phoneExt":26,"email":26},"Xuli Meng",{"facility":115,"status":45,"city":116,"state":26,"zip":26,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Technical University of Munich","Munich","Germany","DE",{"type":52,"coordinates":120},[121,122],11.57549,48.13743,{"lat":122,"lon":121},[125],{"name":126,"role":34,"phone":26,"phoneExt":26,"email":26},"Stefan Paepke",{"type":128,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100436800","breast-mesh-used-in-two-staged-breast-reconstruction-100436800",false,"NCT04967976","Breast Mesh Used in Two-staged Breast Reconstruction","A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.","Inclusion Criteria:\n\n1. Diagnosed with breast cancer\n2. More than 18 years old\n3. Karnofsky Performance Status (KPS) larger than 80\n4. No clinical or imaging evidence of distant metastasis\n5. BMI \\\u003C 35kg\u002Fm2\n6. Patients with no or mild breast ptosis\n7. No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.\n8. Mental Health Patient\n\n   \\-\n\n   Exclusion Criteria:\n\n1\\. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast\u002Fchest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug\u002Falcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion\n\n\\-","FEMALE","18 Years","70 Years",{"count":140,"type":141},300,"ESTIMATED","INTERVENTIONAL",[144],"NA","This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.",[147,148,149,150],"Breast Cancer","Radiation","Breast Reconstruction","Synthetic Mesh",[152,153,154,155],"breast cancer","breast reconstruction","radiation","synthetic mesh","2021-07-19",{"date":158,"type":159},"2021-07-20","ACTUAL",{"date":161,"type":141},"2021-08-01",{"date":163,"type":141},"2026-08-01",{"name":5,"class":6},6]