Breast Neoplasm Malignant Female, Mastectomy, Segmental
Conditions
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.
Detailed description
Participants will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan: * Screening * Pre-surgery treatment * Surgery and study device implant * Post-surgery follow-up up to 5 years
Interventions
DEVICEREGENERA breast implant implantation
Each patient will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan: * Screening * Pre-surgery treatment * Surgery and study device implant * Post-surgery follow-up
Sponsors
Tensive SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse events (AEs) with a causal relationship to REGENERA at 3 months. | 3 months | The rate of AEs with a causal relationship to REGENERA should be \<5% at 3 months after implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean investigator's satisfaction on the implanting procedure at 1week. | 1 week after implant | At least 7 in a 0-10 Visual Analogue Scale, VAS. |
| Mean investigator's satisfaction on REGENERA usability during surgery at 1 week. | 1 week after implant | At least 40 in an "ad hoc" questionnaire (12-60 scale). |
| Mean investigator's satisfaction on overall surgical procedure and clinical outcome of the patient at 12 months. | 12 months | At least 7 in a 0-10 Visual Analogue Scale, VAS. |
| Number of interference events of REGENERA with ultrasound imaging technique, through the completion of a questionnaire by the investigators. | After 6 and 12 months | An imaging evaluation questionnaire will be provided for investigators to fill out. |
| Number of interference events of REGENERA with mammography imaging technique, through the completion of a questionnaire by the investigators. | After 12 months | An imaging evaluation questionnaire will be provided for investigators to fill out. |
| Number of interference events of REGENERA with MRI (with and without contrast) imaging technique, through the completion of a questionnaire by the investigators. | After 6 and 18 months | An imaging evaluation questionnaire will be provided for investigators to fill out. |
| Rate of serious adverse events (SAEs) with a causal relationship to REGENERA after 3 months and up to 18 months. | After 3 months and up to 18 months | The rate of REGENERA-related SAEs should be \<5% at each follow-up after 3 months and up to 18 months. |
| Rate of SAEs with a causal relationship to REGENERA after 18 months and up to 5 years. | After 18 months and up to 5 years | The rate of REGENERA-related SAEs should be \<7% at each follow-up after 18 months and up to 5 years. |
Countries
Italy, Spain
Outcome results
None listed