A Pilot Study of REGENERA Implant in Localized Non- Malignant Breast Lesions Treated by Excision or Lumpectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tensive SRL
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Cumulative number of all Serious Adverse Events
Study Overview
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 excision or lumpectomy in whom the tissue removed is replaced by REGENERA.
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 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:
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To assess the safety of the implant procedure
-
To assess the feasibility of the implant procedure
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To evaluate the performance of REGENERA breast implant:
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In replacing the removed tissue
-
In potential interference with current diagnostic standard of care imaging procedures
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On patient's quality of life and satisfaction
-
On investigator's satisfaction.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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).
Arms & Interventions
Single arm 1
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.
Intervention: REGENERA (Device)
Outcomes
Primary Outcomes
Cumulative number of all Serious Adverse Events
Time Frame: at 6 months from implantion of the device
Cumulative number of Serious Adverse Events collected throughout the study and associated with the REGENERA implant device (Adverse Device Effects)
Secondary Outcomes
- Cumulative number of all Adverse Events associated with the surgical procedure(at 6 months from the implantation of the device)
- Patient Quality of Life measured through Breast-Q questionnaire(at 1 month from the implantation of the device (Day 0), 6 months from Day 0 versus 2 weeks before Day 0)
- Measurement of changes in breast appeareance before and after surgery through antropomorphic chest parameters(at 2 weeks before the implantation of the device (Day 0), 1 week from Day 0, 3 months from Day 0, 6 months from Day 0)
- Measurement of the reduction of reliability of the currently used diagnostic imaging techniques(at 1 week from the implantation of the device (Day 0), 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0)
- Patient pain measurement through a Visual Analogue Scale(at 2 weeks before the implantation of the device (Day 0), Day 0, 1 week from Day 0, 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0)
- Measure of the Investigator's satisfaction on the implantation procedure, through a Visual Analogue Scale (VAS) and an ad-hoc questionnaire(implantation satisfaction (VAS + ad-hoc questionnaire) at the implantation of the device (Day 0) and REGENERA performance (VAS) at 6 months from Day 0)