NCT05941299 Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy

Eligibility & Interventions

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You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 92 participants in total. It began in 2023-09-29 with a primary completion date of 2025-02-28.

Brief Summary

The goals of this clinical trial are: * demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions * 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.

Eligibility Criteria

Inclusion Criteria: * Female adult subject aged 40-70 years. * Subject diagnosed with malignant breast lesion: * monolateral nodular infiltrative carcinoma, * without microcalcification, * single or multifocal, * included in an area with a maximum diameter of 4 cm, * non-metastatic (M0). * Subject with clinically negative axilla. * 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. * Confirmation of malignant lesion (pT1, pT2, pN0, pN1) with no discordance between biopsy and radiological imaging. * Adequate hematopoietic functions. * Good general health and mentally sound. * Subject able and willing to give written informed consent form. Exclusion Criteria: * Subject with actual concomitant benign breast lesion (B2 and B3), unless present in the same mammary quadrant or in the contralateral breast. * Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease. * Axillary dissection planned as part of the breast lesion surgery. * History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study. * Skin retraction at the breast to be operated. * Infection of the surgical site confirmed pre-operatively by clinical examination. * Abnormal blood sugar and glycosylated hemoglobin. * Hard smoker (more than 10 cigarettes a day). * Acute or chronic severe renal insufficiency (creatinine values \>180 μmol/l). * History of severe asthma or allergies (including allergy to anesthetics or contrast media). * Autoimmune disease. * Subjects who are known to be carriers of BCRA mutation. * Inability to undergo MRI or allergy to contrast media. * Systemic infections in an active phase. * Immunocompromised patients (HIV). * Pregnant or breastfeeding woman or woman who has nursed a child within 3 months prior to enrolment in the study. * Subject who has participated in another interventional study within the past 3 months. * Subject who received immunosuppressant therapy in the last 3 months. * History of substance abuse (drug or alcohol). * Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).

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