[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mastectomy-segmental\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mastectomy-segmental":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100619469","acellular-dermal-matrixsurederm-bcs-in-breast-conserving-surgery-for-breast-cancer-patients-100619469",false,"NCT07345026","Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients","Clinical Efficacy of Acellular Dermal Matrix (Product Name: SureDerm BCS) in Breast Cancer Patients Undergoing Breast-Conserving Surgery","Inclusion Criteria:\n\n* Female patients aged 20 to 75 years\n* Diagnosed with unilateral breast cancer (ICD-10 code: C50, D05) and treated with breast-conserving surgery\n* Agreed to the use of acellular dermal matrix (ADM) during surgery\n* Histologically confirmed primary breast cancer\n* Patients who received neoadjuvant chemotherapy are eligible\n* Planned to receive standard postoperative treatment, including adjuvant radiotherapy\n* Voluntarily decided to participate in the study and provided written informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastasis\n* Presence of infectious disease, autoimmune disease (e.g., specific rheumatologic disorders), or bleeding\u002Fcoagulation disorders\n* Known adverse reactions to all first-line antibiotics\n* Suspected inflammatory infection of the breast prior to surgery\n* Pregnant women at the time of enrollment\n* Definite contraindications to the use of acellular dermal matrix\n* Contraindications to radiotherapy\n* Male patients\n* History of another malignancy diagnosed within the past 5 years\n* Patients deemed unsuitable for participation due to difficulty in data collection as judged by the investigator\n* Patients unable to understand or complete the study questionnaires","FEMALE","20 Years","75 Years",{"count":20,"type":21},116,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate whether the use of an acellular dermal matrix (SureDerm) can improve cosmetic satisfaction and is safe in women with breast cancer undergoing breast-conserving surgery.\n\nThe main questions it aims to answer are:\n\n1. Does the use of SureDerm improve patient-reported cosmetic satisfaction after breast-conserving surgery?\n2. Is the use of SureDerm safe in terms of complication rates compared to standard surgery without SureDerm?\n\nResearchers will compare patients receiving SureDerm during surgery with patients undergoing standard breast-conserving surgery without SureDerm to see if cosmetic results and safety differ between the groups.\n\nParticipants will:\n\n* Undergo breast-conserving surgery, with or without SureDerm (assigned randomly)\n* Receive standard postoperative radiotherapy\n* Complete questionnaires about cosmetic satisfaction (Breast-Q) at baseline, 1 month, and 12 months after surgery\n* Be followed for complications and cosmetic assessments by physicians",[27,28],"Breast Neoplasms","Mastectomy, Segmental",[30,31,32,33],"Breast Cancer","Breast-Conserving Surgery","Acellular Dermal Matrix","Oncoplastic Surgery","NOT_YET_RECRUITING","2026-01-07",{"date":37,"type":38},"2026-01-15","ACTUAL",{"date":40,"type":21},"2026-01-08",{"date":42,"type":21},"2028-04-30",{"name":44,"class":45},"Seoul St. Mary's Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100511581","safety-and-performance-of-regenera-breast-implant-in-women-affected-by-malignant-breast-lesion-treated-by-lumpectomy-100511581","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).","40 Years","70 Years",{"count":57,"type":21},92,[24],"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.",[28,61],"Breast Neoplasm Malignant Female","RECRUITING","2024-11-20",{"date":65,"type":38},"2024-11-22",{"date":67,"type":38},"2023-09-29",{"date":69,"type":21},"2029-12-30",{"name":71,"class":72},"Tensive SRL","INDUSTRY",3]