Clinical Trial to Demonstrate the Safety and Performance of REGENERA Breast Implant in 40-70 Years Old Women Affected by Malignant Breast Lesion Treated by Lumpectomy

Trial Title: Clinical Trial to Demonstrate the Safety and Performance of REGENERA Breast Implant in 40-70 Years Old Women Affected by Malignant Breast Lesion Treated by Lumpectomy

NCT ID: NCT05941299

Condition: Mastectomy, Segmental
Breast Neoplasm Malignant Female

Conditions: Official terms:
Breast Neoplasms
Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: REGENERA breast implant implantation
Description: 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
Arm group label: REGENERA breast implant implantation

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. 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

Criteria for 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).

Gender: Female

Minimum age: 40 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: IEO Istituto Europeo di Oncologia

Address:
City: Milan
Zip: 20141
Country: Italy

Status: Recruiting

Contact:
Last name: Mario Rietjens

Facility:
Name: A.O.U. Pisana - Ospedale Santa Chiara

Address:
City: Pisa
Zip: 56126
Country: Italy

Status: Recruiting

Contact:
Last name: Manuela Roncella

Facility:
Name: Complejo Hospitalario Universitario A Coruña

Address:
City: A Coruña
Zip: 15001
Country: Spain

Status: Recruiting

Contact:
Last name: Benigno Acea Nebril

Start date: September 29, 2023

Completion date: December 30, 2029

Lead sponsor:
Agency: Tensive SRL
Agency class: Industry

Source: Tensive SRL

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05941299