REGENERA Implant in Excised Non-Malignant Breast Lesions

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of REGENERA Implant in Localized Non- Malignant Breast Lesions Treated by Excision or Lumpectomy

Conditions
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Benign Breast Disease

Intervention / Treatment
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* Device: REGENERA


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm 1<br>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. | Device: REGENERA<br>* REGENERA breast implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative number of all Serious Adverse Events | Cumulative number of Serious Adverse Events collected throughout the study and associated with the REGENERA implant device (Adverse Device Effects) | at 6 months from implantion of the device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of changes in breast appeareance before and after surgery through antropomorphic chest parameters | Assess breast appearance before and after surgery with photo and chest measurement. In particular, the following measures, in cm, will be evaluated: sternal notch to nipple (SN), nipple to inframammary fold (NF), nipple to sternum (NM), the areola diameter and the ptosis grade. | 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 | Assess the potential interference with current, standard- of-care imaging techniques by evaluation of the following factors: (1) for ultrasound, the possible attenuation of the acoustic beam preventing the visualization of the tissue behind the implant; (2) for magnetic resonance imaging, possible creation, caused by the implant, of images mimicking a pre-invasive or invasive lesion. | 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 Quality of Life measured through Breast-Q questionnaire | Measure changes in patient's Quality of Life (QoL) and satisfaction through Breast-Q™ questionnaire (pre- and post-operative Breast Conserving Therapy (BCT) module version 2.0) after surgery versus baseline (prior implantation surgery). Breast-Q™ questionnaire includes 7 scales measuring (i) breast satisfaction, (ii) psychosocial well-being, (iii) physical breast well-being, (iv) sexual well-being, (v) patient experience satisfaction with the surgeon, (vi) patient experience satisfaction with the medical equip and (vii) patient experience satisfaction with the hospital staff. Each scale is evaluated by defined questions where the patient has to answer by a numeric scale. For example: 1, non of the time; 2, a little of the time; 3, some of the time; 4, most of the time; 5, all of the time. Once the questions are answered, a conversion table is applied to convert the raw scale summed score into a score from 0 (worst) to 100 (best). | at 1 month from the implantation of the device (Day 0), 6 months from Day 0 versus 2 weeks before Day 0 | 
| Patient pain measurement through a Visual Analogue Scale | Assess pain intensity with a Visual Analogue Scale (VAS) at each study visit. The VAS measure will be made through a cross (X) that the patient has to put along a bar. The left margin of the bar corresponds to no pain (0 score) and the right margin to worst pain (10 score). | 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 | Assess investigator's satisfaction on the implantation procedure, through a Visual Analogue Scale (VAS) and an ad-hoc questionnaire (developed by the Sponsor), and on the REGENERA performance, through a VAS scale. The VAS measure will be made through a cross (X) that the patient has to put along a bar. The left margin of the bar corresponds to no pain (0 score) and the right margin to worst pain (10 score). The ad-hoc questionnaire has a unique scale made of 5 levels (1 corresponds to strongly disagree and 5 corresponds to strongly agree) to be used for each question. As there are 12 questions, 12 is the minimum score and 60 is the maximum score as a sum of all answers. | implantation satisfaction (VAS + ad-hoc questionnaire) at the implantation of the device (Day 0) and REGENERA performance (VAS) at 6 months from Day 0 | 
| Cumulative number of all Adverse Events associated with the surgical procedure | Cumulative number of all Adverse Events associated with the surgical procedure: number of re-operations and / or explants due to seroma, hematoma, infection, wound dehiscence, skin retraction, acute inflammatory reactions, allergic reactions to the device, persistent pain. | at 6 months from the implantation of the device | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumpectomy, Bio-absorbable