[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579370":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":18,"locations":25,"responsibleParty":54,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":10,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University Hospital A Coruña","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Video assisted mastectomy",null,"Patients with a video-assisted nipple skin sparing mastectomy",[13],"Other: Video assisted mastectomy",[15],{"type":6,"name":9,"description":16,"armGroupLabels":17,"otherNames":10},"Nipple Skin sparing mastectomy assisted by endoscopic or robotic",[9],[19],{"name":20,"role":21,"phone":22,"phoneExt":23,"email":24},"Alejandra García Novoa, PhD MD","CONTACT","981178000","296113","maria.alejandra.garcia.novoa@sergas.es",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4","RECRUITING","A Coruña","Galicia","15006","Spain","ES",{"type":35,"coordinates":36},"Point",[37,38],-8.396,43.37135,{"lat":38,"lon":37},[41,46,50,53],{"name":42,"role":21,"phone":43,"phoneExt":44,"email":45},"Alejandra García Novoa, Ph.D","0034981178000","296158","malejandagarcianovoa@gmail.com",{"name":47,"role":21,"phone":48,"phoneExt":44,"email":49},"Benigno Acea Nebril, Ph.D.","+34981178000","benigno.acea.nebril@sergas.es",{"name":51,"role":52,"phone":10,"phoneExt":10,"email":10},"Benigno Acea Nebril, Ph.D","PRINCIPAL_INVESTIGATOR",{"name":42,"role":52,"phone":10,"phoneExt":10,"email":10},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Alejandra García-Novoa","Principal Investigator","100579370","endoscopyrobotic-assisted-nipple-skin-sparing-mastectomy-100579370",false,"NCT06823414","Endoscopy\u002FRobotic Assisted Nipple Skin Sparing Mastectomy","Endoscopy\u002FRobotic Assisted Nipple Skin Sparing Mastectomy and Inmediate Reconstruction With Prepectoral Implant. Prospective Study for the Evaluation of the Feasibility and Safety of the Technique, Quality of Life and Cosmetic Results","Inclusion Criteria:\n\n* Women who require a mastectomy and who do not require skin reduction or resection are included. Women with both breast cancer and those at high risk for breast cancer are included.\n\nExclusion Criteria:\n\n* Sarcomas of the breast.\n* Benign breast tumors.\n* Prepectoral reconstruction with expansion.\n* Impossibility to preserve the skin.\n* Need for reduction pattern\n* Inability to perform an MRI during follow-up (obesity, claustrophobia, etc.).\n* Inability to complete the BREAST-Q™ questionnaire due to the patient's cognitive alterations.\n* Refusal of the patient to participate in the study.","FEMALE","18 Years",{"count":68,"type":69},126,"ESTIMATED","5 Years","OBSERVATIONAL","Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.",[74,75,76],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Breast Cancer Non-invasive Breast Cancer","High Risk Breast Carcinoma","2025-02-06",{"date":79,"type":80},"2025-02-12","ACTUAL",{"date":82,"type":80},"2025-02-01",{"date":84,"type":69},"2034-04-01",{"name":56,"class":6},1]