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

NCT05941299 | Recruiting

• 1 other identifier: Tens-BBC/003/2021
• Study Type: interventional
• Target: 92
• Locations: 2 countries
• Sites: 3

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.

Conditions

Mastectomy, Segmental; Breast Neoplasm Malignant Female

Outcome Measures

Primary Outcomes (1)

• Rate of adverse events (AEs) with a causal relationship to REGENERA at 3 months.

  The rate of AEs with a causal relationship to REGENERA should be \<5% at 3 months after implant.

  3 months

Secondary Outcomes (8)

• Mean investigator's satisfaction on the implanting procedure at 1week.

  1 week after implant

• Mean investigator's satisfaction on REGENERA usability during surgery at 1 week.

  1 week after implant

• Mean investigator's satisfaction on overall surgical procedure and clinical outcome of the patient at 12 months.

  12 months

• Number of interference events of REGENERA with ultrasound imaging technique, through the completion of a questionnaire by the investigators.

  After 6 and 12 months

• Number of interference events of REGENERA with mammography imaging technique, through the completion of a questionnaire by the investigators.

  After 12 months

Study Arms (1)

REGENERA breast implant implantation

EXPERIMENTAL

Single monolateral breast implant

Device: REGENERA breast implant implantation

Interventions

REGENERA breast implant implantation DEVICE

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

REGENERA breast implant implantation

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tensive SRL: lead

Study Sites (3)

IEO Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

A.O.U. Pisana - Ospedale Santa Chiara

Pisa, 56126, Italy

RECRUITING

Complejo Hospitalario Universitario A Coruña

A Coruña, 15001, Spain

RECRUITING

Related Publications (1)

• Lisa AVE, Bottoni M, Ghilli M, Mariniello MD, Intra M, Belloni LM, Mattar D, Cossu MC, Montrone S, Tamplenizza M, Gerges I, Tocchio A, Acea B, Roncella M, Rietjens M. Volume replacement procedure adopting biomaterial: early considerations from a multicentric study. Updates Surg. 2025 Sep;77(5):1665-1671. doi: 10.1007/s13304-025-02212-2. Epub 2025 Apr 28.

  PMID: 40295450 DERIVED

Central Study Contacts

Margherita Tamplenizza

CONTACT

+39 0256660185; margherita.tamplenizza@tensivemed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 12, 2023
• Study Start: September 29, 2023
• Primary Completion: February 28, 2025
• Study Completion (Estimated): December 30, 2029
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); ES (1)