Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy
- Conditions
- Mastectomy, SegmentalBreast Neoplasm Malignant Female
- Interventions
- Device: REGENERA breast implant implantation
- Registration Number
- NCT05941299
- Lead Sponsor
- Tensive SRL
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 92
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description REGENERA breast implant implantation REGENERA breast implant implantation -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 the implanting procedure at 1week. 1 week after implant 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.
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.
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 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.
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.
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.
Trial Locations
- Locations (3)
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
IEO Istituto Europeo di Oncologia
🇮🇹Milan, Italy
A.O.U. Pisana - Ospedale Santa Chiara
🇮🇹Pisa, Italy