Clinical trial NCT05941299: Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy
Official title: A Pivotal Study of REGENERA Implant in Malignant Breast Lesion Treated by Lumpectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mastectomy, Segmental
Breast Neoplasm Malignant Female
Lead sponsor: Tensive SRL
Sponsor class: INDUSTRY
First posted: 2023-07-12
Enrollment: 92
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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).

Primary outcomes:
measure: Rate of adverse events (AEs) with a causal relationship to REGENERA at 3 months.
timeFrame: 3 months
Secondary outcomes:
measure: Mean investigator's satisfaction on the implanting procedure at 1week.
timeFrame: 1 week after implant
measure: Mean investigator's satisfaction on REGENERA usability during surgery at 1 week.
timeFrame: 1 week after implant
measure: Mean investigator's satisfaction on overall surgical procedure and clinical outcome of the patient at 12 months.
timeFrame: 12 months
measure: Number of interference events of REGENERA with ultrasound imaging technique, through the completion of a questionnaire by the investigators.
timeFrame: After 6 and 12 months
measure: Number of interference events of REGENERA with mammography imaging technique, through the completion of a questionnaire by the investigators.
timeFrame: After 12 months
measure: Number of interference events of REGENERA with MRI (with and without contrast) imaging technique, through the completion of a questionnaire by the investigators.
timeFrame: After 6 and 18 months
measure: Rate of serious adverse events (SAEs) with a causal relationship to REGENERA after 3 months and up to 18 months.
timeFrame: After 3 months and up to 18 months
measure: Rate of SAEs with a causal relationship to REGENERA after 18 months and up to 5 years.
timeFrame: After 18 months and up to 5 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IEO Istituto Europeo di Oncologia
city: Pisa
country: Italy
facility: A.O.U. Pisana - Ospedale Santa Chiara
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
Study officials:
References: