[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tensive SRL\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":20,"type":21},92,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Mastectomy, Segmental","Breast Neoplasm Malignant Female","RECRUITING","2024-11-20",{"date":32,"type":33},"2024-11-22","ACTUAL",{"date":35,"type":33},"2023-09-29",{"date":37,"type":21},"2029-12-30",{"name":39,"class":40},"Tensive SRL","INDUSTRY",3,""]