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

• ClinicalTrials.gov Identifier: NCT05941299
• Recruitment Status: Recruiting
• First Posted: July 12, 2023
• Last Update Posted: April 11, 2024
• Sponsor: Tensive SRL
• Information provided by (Responsible Party): Tensive SRL

Study Description

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.

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

Condition or disease	Intervention/treatment	Phase
Mastectomy, Segmental; Breast Neoplasm Malignant Female	Device: REGENERA breast implant implantation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 92 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Pivotal Study of REGENERA Implant in Malignant Breast Lesion Treated by Lumpectomy
• Actual Study Start Date: September 29, 2023
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 30, 2029

Arms and Interventions

Arm	Intervention/treatment
Experimental: REGENERA breast implant implantation	Device: REGENERA breast implant implantation; 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

Outcome Measures

Primary Outcome Measures :

1. Rate of adverse events (AEs) with a causal relationship to REGENERA at 3 months. [ Time Frame: 3 months ]
   The rate of AEs with a causal relationship to REGENERA should be <5% at 3 months after implant.

Secondary Outcome Measures :

1. Mean investigator's satisfaction on the implanting procedure at 1week. [ Time Frame: 1 week after implant ]
   At least 7 in a 0-10 Visual Analogue Scale, VAS.
2. Mean investigator's satisfaction on REGENERA usability during surgery at 1 week. [ Time Frame: 1 week after implant ]
   At least 40 in an "ad hoc" questionnaire (12-60 scale).
3. Mean investigator's satisfaction on overall surgical procedure and clinical outcome of the patient at 12 months. [ Time Frame: 12 months ]
   At least 7 in a 0-10 Visual Analogue Scale, VAS.
4. Number of interference events of REGENERA with ultrasound imaging technique, through the completion of a questionnaire by the investigators. [ Time Frame: After 6 and 12 months ]
   An imaging evaluation questionnaire will be provided for investigators to fill out.
5. Number of interference events of REGENERA with mammography imaging technique, through the completion of a questionnaire by the investigators. [ Time Frame: After 12 months ]
   An imaging evaluation questionnaire will be provided for investigators to fill out.
6. Number of interference events of REGENERA with MRI (with and without contrast) imaging technique, through the completion of a questionnaire by the investigators. [ Time Frame: After 6 and 18 months ]
   An imaging evaluation questionnaire will be provided for investigators to fill out.
7. Rate of serious adverse events (SAEs) with a causal relationship to REGENERA after 3 months and up to 18 months. [ Time Frame: 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.
8. Rate of SAEs with a causal relationship to REGENERA after 18 months and up to 5 years. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Contacts

Contact: Margherita Tamplenizza; +39 0256660185; margherita.tamplenizza@tensivemed.com

Locations

Italy

IEO Istituto Europeo di Oncologia; Recruiting

Milan, Italy, 20141

Contact: Mario Rietjens

A.O.U. Pisana - Ospedale Santa Chiara; Recruiting

Pisa, Italy, 56126

Contact: Manuela Roncella

Spain

Complejo Hospitalario Universitario A Coruña; Recruiting

A Coruña, Spain, 15001

Contact: Benigno Acea Nebril

Sponsors and Collaborators

Tensive SRL

More Information

• Responsible Party: Tensive SRL
• ClinicalTrials.gov Identifier: NCT05941299
• Other Study ID Numbers: Tens-BBC/003/2021
• First Posted: July 12, 2023
• Last Update Posted: April 11, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases