REGENERA Implant in Excised Non-Malignant Breast Lesions

Tensive

Status: Completed

Conditions: Benign Breast Disease

Treatments: Device: REGENERA

Study type: Interventional

Funder types: Industry

Identifiers

NCT04131972

Tens-BBC/001/2017

Details and patient eligibility

About

The purpose of this First-in-Human pilot study is to evaluate the safety and performance of REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom the tissue removed is replaced by REGENERA.

Full description

This is a pre-market, single center, interventional, open label, non-comparative, pilot first-in-human study on adult female patients with localized non-malignant breast lesion. This study will include an enrollment period of 12 months and 6 months study duration per patient.

The primary objective of this study is to demonstrate the safety profile of a new breast implant (REGENERA) in excision or lumpectomy of non-malignant breast lesions.

The secondary objectives of this study are:

• To assess the safety of the implant procedure

• To assess the feasibility of the implant procedure

• To evaluate the performance of REGENERA breast implant:

  • In replacing the removed tissue
  • In potential interference with current diagnostic standard of care imaging procedures
  • On patient's quality of life and satisfaction
  • On investigator's satisfaction.

Enrollment: 15 patients

Sex: Female

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female patients aged 20-85 years
2. Patients eligible for excision or lumpectomy, as per current surgical guidelines
3. Volume deficit compatible with an implant volume of 70 cc
4. Adequate hematopoietic functions
5. Good general health and mentally sound
6. Confirmation of non-malignant lesion (B2 and B3) with no discordance between biopsy and radiological imaging
7. Patients able and willing to give written informed consent form

Exclusion criteria

1. Pregnant or breastfeeding women or women who have nursed a child three months within enrolment in the study
2. Non-malignant lesions (B2 and B3) with discordance between biopsy and radiological imaging
3. Infection of the surgical site confirmed pre-operatively by clinical examination
4. Acute or chronic severe renal insufficiency (creatinine values < 180 μmol/L)
5. History of severe asthma or allergies (including to anaesthetics or contrast media)
6. Autoimmune disease
7. Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease
8. Subject who are known to be carriers of BCRA mutation
9. Inability to undergo MRI or allergy to contrast media
10. Systemic infections in active phase
11. Immunocompromised patients (HIV)
12. Subjects who have participated in another study within the past 3 months
13. Patients who received immunosuppressant therapy in the last 3 months
14. Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Single arm 1

Experimental group

Description:

Each patient will be planned to perform 7 study visits and at the second visit excision / lumpectomy and REGENERA implant will be performed during the same surgical intervention.

Treatment:

Device: REGENERA