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

Tensive

Status

Enrolling

Conditions

Mastectomy, Segmental

Breast Neoplasm Malignant Female

Treatments

Device: REGENERA breast implant implantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT05941299

Tens-BBC/003/2021

Details and patient eligibility

About

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.

Full 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

Enrollment

92 estimated patients

Sex

Female

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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).