[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100382607":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":110,"collaborators":112,"id":115,"slug":10,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":10,"enrollmentInfo":124,"targetDuration":10,"studyType":127,"phases":10,"briefSummary":128,"conditions":129,"keywords":10,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Maastricht University Medical Center","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Autologous Fat Transfer",null,[12],"Procedure: Autologous Fat Transfer",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"PROCEDURE","Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.",[9],[19],"Lipofilling",[21],{"name":22,"affiliation":5,"role":23},"Andrzej Piatkowski de Grzymala, MD, MSc","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Jamilla Wederfoort, MD, MSc","CONTACT","0031-(0)43 387 2308","sander.schop@mumc.nl",[31,44,56,64,72,80,88,99],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":10},"Maastricht University Medical Center+","ENROLLING_BY_INVITATION","Maastricht","Limburg","6229 HX","Netherlands",{"type":39,"coordinates":40},"Point",[41,42],5.68889,50.84833,{"lat":42,"lon":41},{"facility":45,"status":46,"city":47,"state":35,"zip":10,"country":37,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Viecuri Venlo","RECRUITING","Venlo",{"type":39,"coordinates":49},[50,51],6.16806,51.37,{"lat":51,"lon":50},[54],{"name":55,"role":27,"phone":10,"phoneExt":10,"email":10},"An Deliaert, MD, MsC",{"facility":57,"status":33,"city":58,"state":10,"zip":10,"country":37,"cosmosGeoPoint":59,"geoPoint":63,"contacts":10},"Amsterdam University Medical Center (VUMC)","Amsterdam",{"type":39,"coordinates":60},[61,62],4.88969,52.37403,{"lat":62,"lon":61},{"facility":65,"status":33,"city":66,"state":10,"zip":10,"country":37,"cosmosGeoPoint":67,"geoPoint":71,"contacts":10},"Rijnstate","Arnhem",{"type":39,"coordinates":68},[69,70],5.91111,51.98,{"lat":70,"lon":69},{"facility":73,"status":33,"city":74,"state":10,"zip":10,"country":37,"cosmosGeoPoint":75,"geoPoint":79,"contacts":10},"Alexander Monro, Bilthoven","Bilthoven",{"type":39,"coordinates":76},[77,78],5.20139,52.13,{"lat":78,"lon":77},{"facility":81,"status":33,"city":82,"state":10,"zip":10,"country":37,"cosmosGeoPoint":83,"geoPoint":87,"contacts":10},"Amphia","Breda",{"type":39,"coordinates":84},[85,86],4.77596,51.58656,{"lat":86,"lon":85},{"facility":89,"status":46,"city":90,"state":10,"zip":10,"country":37,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Ziekenhuis groep Twente (ZGT)","Hengelo",{"type":39,"coordinates":92},[93,94],6.79306,52.26583,{"lat":94,"lon":93},[97],{"name":98,"role":27,"phone":10,"phoneExt":10,"email":10},"Ute Schmidbauer, MD, MsC",{"facility":100,"status":46,"city":101,"state":10,"zip":10,"country":37,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Medical Center Leeuwarden","Leeuwarden",{"type":39,"coordinates":103},[104,105],5.80973,53.20271,{"lat":105,"lon":104},[108],{"name":109,"role":27,"phone":10,"phoneExt":10,"email":10},"Chantal Mouës, MD, MsC",{"type":111,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[113],{"name":114,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development","100382607",false,"NCT04261829","AFT: Introduction of a Full Breast Reconstructive Method","Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method","BREAST-II","Inclusion Criteria:\n\n* Female gender\n* Age of 18 years and older\n* History or in candidate for a mastectomy procedure in the near future\n* Patients undergoing preventive mastectomy\n* Patients' choice to undergo a breast reconstruction\n* Wanting to participate in this study\n* Patient is able to wear the external expansion device\n\nExclusion Criteria:\n\n* Active smoker or a history of smoking 4 weeks prior to surgery\n* Current substance abuse\n* History of lidocaine allergy\n* History of silicone allergy\n* 4 weeks or less after chemotherapy\n* History of radiation therapy in the breast region\n* Oncological treatment includes radiotherapy after mastectomy\n* Kidney disease\n* Steroid dependent asthma (daily or weekly) or other diseases\n* Immune-suppressed or compromised disease\n* Uncontrolled diabetes\n* BMI\\>30\n* Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C\n* Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction\n* The treating plastic surgeon has strong doubts on the patient's treatment compliance","FEMALE","18 Years",{"count":125,"type":126},350,"ESTIMATED","OBSERVATIONAL","A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.",[130,131,132],"Breast Cancer","Reconstructive Surgery","Breast Reconstruction","2021-07-22",{"date":135,"type":136},"2021-07-29","ACTUAL",{"date":138,"type":136},"2020-12-09",{"date":140,"type":126},"2026-10",{"name":5,"class":6},8]