[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511581":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":69,"collaborators":19,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":19,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":19,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Tensive SRL","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"REGENERA breast implant implantation","EXPERIMENTAL","Single monolateral breast implant",[13],"Device: REGENERA breast implant implantation",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Each patient will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan:\n\n* Screening\n* Pre-surgery treatment\n* Surgery and study device implant\n* Post-surgery follow-up",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Margherita Tamplenizza","CONTACT","+39 0256660185","margherita.tamplenizza@tensivemed.com",[27,43,55],{"facility":28,"status":29,"city":30,"state":19,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"IEO Istituto Europeo di Oncologia","RECRUITING","Milan","20141","Italy","IT",{"type":35,"coordinates":36},"Point",[37,38],9.18951,45.46427,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":19,"phoneExt":19,"email":19},"Mario Rietjens",{"facility":44,"status":29,"city":45,"state":19,"zip":46,"country":32,"countryCode":33,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"A.O.U. Pisana - Ospedale Santa Chiara","Pisa","56126",{"type":35,"coordinates":48},[49,50],10.4036,43.70853,{"lat":50,"lon":49},[53],{"name":54,"role":23,"phone":19,"phoneExt":19,"email":19},"Manuela Roncella",{"facility":56,"status":29,"city":57,"state":19,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Complejo Hospitalario Universitario A Coruña","A Coruña","15001","Spain","ES",{"type":35,"coordinates":62},[63,64],-8.396,43.37135,{"lat":64,"lon":63},[67],{"name":68,"role":23,"phone":19,"phoneExt":19,"email":19},"Benigno Acea Nebril",{"type":70,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100511581","safety-and-performance-of-regenera-breast-implant-in-women-affected-by-malignant-breast-lesion-treated-by-lumpectomy-100511581",false,"NCT05941299","Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy","A Pivotal Study of REGENERA Implant in Malignant Breast Lesion Treated by Lumpectomy","Inclusion Criteria:\n\n* Female adult subject aged 40-70 years.\n* Subject diagnosed with malignant breast lesion:\n* monolateral nodular infiltrative carcinoma,\n* without microcalcification,\n* single or multifocal,\n* included in an area with a maximum diameter of 4 cm,\n* non-metastatic (M0).\n* Subject with clinically negative axilla.\n* Subject considered eligible for conservative breast surgery - BCS (Breast-Conserving Surgery, lumpectomy or quadrantectomy), leaving a volume deficit compatible with a REGENERA implant (available in two dried sizes) volume of 70 ml or 100 ml.\n* Confirmation of malignant lesion (pT1, pT2, pN0, pN1) with no discordance between biopsy and radiological imaging.\n* Adequate hematopoietic functions.\n* Good general health and mentally sound.\n* Subject able and willing to give written informed consent form.\n\nExclusion Criteria:\n\n* Subject with actual concomitant benign breast lesion (B2 and B3), unless present in the same mammary quadrant or in the contralateral breast.\n* Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease.\n* Axillary dissection planned as part of the breast lesion surgery.\n* History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study.\n* Skin retraction at the breast to be operated.\n* Infection of the surgical site confirmed pre-operatively by clinical examination.\n* Abnormal blood sugar and glycosylated hemoglobin.\n* Hard smoker (more than 10 cigarettes a day).\n* Acute or chronic severe renal insufficiency (creatinine values \\>180 μmol\u002Fl).\n* History of severe asthma or allergies (including allergy to anesthetics or contrast media).\n* Autoimmune disease.\n* Subjects who are known to be carriers of BCRA mutation.\n* Inability to undergo MRI or allergy to contrast media.\n* Systemic infections in an active phase.\n* Immunocompromised patients (HIV).\n* Pregnant or breastfeeding woman or woman who has nursed a child within 3 months prior to enrolment in the study.\n* Subject who has participated in another interventional study within the past 3 months.\n* Subject who received immunosuppressant therapy in the last 3 months.\n* History of substance abuse (drug or alcohol).\n* Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).","FEMALE","40 Years","70 Years",{"count":82,"type":83},92,"ESTIMATED","INTERVENTIONAL",[86],"NA","The goals of this clinical trial are:\n\n* demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions\n* demonstrate the safety and performance of REGENERA in terms of investigator's satisfaction, potential interference with current standard-of-care imaging techniques and occurrence of device-related serious adverse events.",[89,90],"Mastectomy, Segmental","Breast Neoplasm Malignant Female","2024-11-20",{"date":93,"type":94},"2024-11-22","ACTUAL",{"date":96,"type":94},"2023-09-29",{"date":98,"type":83},"2029-12-30",{"name":5,"class":6},3]