Status:
COMPLETED
REGENERA Implant in Excised Non-Malignant Breast Lesions
Lead Sponsor:
Tensive SRL
Conditions:
Benign Breast Disease
Eligibility:
FEMALE
20-85 years
Phase:
NA
Brief Summary
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 exc...
Detailed 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 includ...
Eligibility Criteria
Inclusion
- Female patients aged 20-85 years
- Patients eligible for excision or lumpectomy, as per current surgical guidelines
- Volume deficit compatible with an implant volume of 70 cc
- Adequate hematopoietic functions
- Good general health and mentally sound
- Confirmation of non-malignant lesion (B2 and B3) with no discordance between biopsy and radiological imaging
- Patients able and willing to give written informed consent form
Exclusion
- Pregnant or breastfeeding women or women who have nursed a child three months within enrolment in the study
- Non-malignant lesions (B2 and B3) with discordance between biopsy and radiological imaging
- Infection of the surgical site confirmed pre-operatively by clinical examination
- Acute or chronic severe renal insufficiency (creatinine values \< 180 μmol/L)
- History of severe asthma or allergies (including to anaesthetics or contrast media)
- Autoimmune disease
- Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease
- Subject who are known to be carriers of BCRA mutation
- Inability to undergo MRI or allergy to contrast media
- Systemic infections in active phase
- Immunocompromised patients (HIV)
- Subjects who have participated in another study within the past 3 months
- Patients who received immunosuppressant therapy in the last 3 months
- Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04131972
Start Date
November 11 2019
End Date
November 27 2021
Last Update
February 8 2022
Active Locations (1)
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1
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126