[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582200":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":33,"responsibleParty":46,"collaborators":18,"id":48,"slug":18,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":18,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":18,"maxAge":18,"enrollmentInfo":55,"targetDuration":18,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":70,"whyStopped":18,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotic Nipple-Sparing Mastectomy","EXPERIMENTAL","Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction",[13],"Other: Robotic Nipple-Sparing Mastectomy",[15],{"type":6,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"Patient will undergo to nipple sparing mastectomy and breast reconstruction, conducted using robot",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Paolo Veronesi, MD","European Istitute of Oncology","PRINCIPAL_INVESTIGATOR",[25,29],{"name":21,"role":26,"phone":27,"phoneExt":18,"email":28},"CONTACT","+39 0294371091","paolo.veronesi@ieo.it",{"name":30,"role":26,"phone":31,"phoneExt":18,"email":32},"Mara Negri","+39 0257489536","mara.negri@ieo.it",[34],{"facility":5,"status":18,"city":35,"state":18,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Milan","20141","Italy",{"type":39,"coordinates":40},"Point",[41,42],9.18951,45.46427,{"lat":42,"lon":41},[45],{"name":21,"role":26,"phone":27,"phoneExt":18,"email":28},{"type":47,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100582200",false,"NCT06860217","Robotic Nipple Sparing Mastectomy with Immediate Reconstruction","Robotic Nipple Sparing Mastectomy with Immediate Reconstruction with Prepectoral Implant: a Single Center, Prospective Trial","Inclusion Criteria:\n\n* Candidates to nipple-sparing mastectomy and immediate breast reconstruction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers\n* Any age\n* Negative preoperative assessment of nipple-areola complex\n* Absence of skin involvement\n* Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section\n* Breast volume ≤ Bra IV\n* No hard smoking (defined as \\\u003C=20 cigarettes\u002Fday)\n* Low and intermediate risk for anesthesia (American Society of Anesthesiologists (ASA) Scale)\n* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.\n* Patients must be accessible for follow-up\n\nExclusion Criteria:\n\n* Previous thoracic radiation therapy for any reason\n* Inflammatory Breast Cancer\n* Pregnancy\n* Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.\n* Uncompensated Diabetes Mellitus","ALL",{"count":56,"type":57},24,"ESTIMATED","INTERVENTIONAL",[60],"NA","Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct implant procedure can impact on perioperative and postoperative period and on oncologic outcome.",[63,64,65],"Breast Cancer","DCIS","BRCA Mutation",[67,68,69],"Robotic Mastectomy","Nipple-sparing mastectomy","Breast reconstruction","NOT_YET_RECRUITING","2025-02-28",{"date":73,"type":74},"2025-03-05","ACTUAL",{"date":76,"type":57},"2025-04",{"date":78,"type":57},"2032-04",{"name":5,"class":6},1]