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

Not Applicable

Recruiting

• Conditions: Mastectomy, Segmental; Breast Neoplasm Malignant Female

• 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

Study Timeline

• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-12
• Study Start: 2023-09-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-02-28
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 92

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

IEO Istituto Europeo di Oncologia; 🇮🇹 Milan, Italy

A.O.U. Pisana - Ospedale Santa Chiara; 🇮🇹 Pisa, Italy

Complejo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, Spain