[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100382607":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":111,"collaborators":113,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":10,"enrollmentInfo":126,"targetDuration":10,"studyType":129,"phases":10,"briefSummary":130,"conditions":131,"keywords":10,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"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",[31,45,57,65,73,81,89,100],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":10},"Maastricht University Medical Center+","ENROLLING_BY_INVITATION","Maastricht","Limburg","6229 HX","Netherlands","NL",{"type":40,"coordinates":41},"Point",[42,43],5.68889,50.84833,{"lat":43,"lon":42},{"facility":46,"status":47,"city":48,"state":35,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"Viecuri Venlo","RECRUITING","Venlo",{"type":40,"coordinates":50},[51,52],6.16806,51.37,{"lat":52,"lon":51},[55],{"name":56,"role":27,"phone":10,"phoneExt":10,"email":10},"An Deliaert, MD, MsC",{"facility":58,"status":33,"city":59,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":60,"geoPoint":64,"contacts":10},"Amsterdam University Medical Center (VUMC)","Amsterdam",{"type":40,"coordinates":61},[62,63],4.88969,52.37403,{"lat":63,"lon":62},{"facility":66,"status":33,"city":67,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":68,"geoPoint":72,"contacts":10},"Rijnstate","Arnhem",{"type":40,"coordinates":69},[70,71],5.91111,51.98,{"lat":71,"lon":70},{"facility":74,"status":33,"city":75,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":76,"geoPoint":80,"contacts":10},"Alexander Monro, Bilthoven","Bilthoven",{"type":40,"coordinates":77},[78,79],5.20139,52.13,{"lat":79,"lon":78},{"facility":82,"status":33,"city":83,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":84,"geoPoint":88,"contacts":10},"Amphia","Breda",{"type":40,"coordinates":85},[86,87],4.77596,51.58656,{"lat":87,"lon":86},{"facility":90,"status":47,"city":91,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Ziekenhuis groep Twente (ZGT)","Hengelo",{"type":40,"coordinates":93},[94,95],6.79306,52.26583,{"lat":95,"lon":94},[98],{"name":99,"role":27,"phone":10,"phoneExt":10,"email":10},"Ute Schmidbauer, MD, MsC",{"facility":101,"status":47,"city":102,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Medical Center Leeuwarden","Leeuwarden",{"type":40,"coordinates":104},[105,106],5.80973,53.20271,{"lat":106,"lon":105},[109],{"name":110,"role":27,"phone":10,"phoneExt":10,"email":10},"Chantal Mouës, MD, MsC",{"type":112,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[114],{"name":115,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development","100382607","aft-introduction-of-a-full-breast-reconstructive-method-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":127,"type":128},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.",[132,133,134],"Breast Cancer","Reconstructive Surgery","Breast Reconstruction","2021-07-22",{"date":137,"type":138},"2021-07-29","ACTUAL",{"date":140,"type":138},"2020-12-09",{"date":142,"type":128},"2026-10",{"name":5,"class":6},8]