Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation

N/AActive Not RecruitingNCT05336526

Symatese Aesthetics88 enrolled

Overview

The purpose of this study is to collect clinical data to evaluate the safety and performance of ESTYME® MATRIX Round microtextured breast implants in patients who receive these silicone gel-filled implants as part of their breast augmentation surgery in primary intention. This study also aims to measure patient and surgeon satisfaction. An initial study of all ESTYME® MATRIX implants was conducted between 2018 and 2021. The purpose of the current EMMA study is to complete the data from this first study on a larger number of implants, and only on the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants range for primary intention breast augmentation, with a view to obtaining marketing authorization (CE marking).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Bilateral Breast Augmentation

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged between 18 and 65 years 2. Eligible for bilateral breast augmentation in primary intention 1. general breast enlargement for cosmetic purposes 2. surgical correction of various congenital or acquired anomalies such as amastia, aplasia, hypomastia, hypoplasia, asymmetries\*, Poland's syndrome\*, ptosis … \* correction of asymmetries and Poland's Syndrome with concomitant augmentation of the second breast (bilateral implantation) 3. Signature of Patient Information Consent (PIC) \& willingness to comply with the protocol assessments and follow up visits 4. Affiliation to the social security regime Exclusion Criteria: 1. Local or systemic infection or abscess anywhere in the body 2. Existing carcinoma or pre-carcinoma of the breast with or without treatment 3. History of subcutaneous mastectomy 4. Subject with previous tissue expansion 5. Diagnosis of active cancer of any type 6. Pregnant subject or intending to become pregnant within three (3) months after the implant procedure (women of childbearing potential must use effective contraception from 1 month before the implantation procedure until 3 months after the implantation procedure) 7. Has breastfed within three (3) months the implant surgery, or is still breastfeeding 8. Tissue characteristics determined as clinically inadequate or unsuitable by the surgeon (i.e. tissue damage resulting from radiation, inadequate tissue or compromised vascularity, known wound healing complications) 9. Has been previously implanted with a silicone implant or history of failure following cosmetic augmentation 10. History of autoimmune disease such as, but not limited to, lupus and scleroderma 11. Any condition or treatment for any condition which, in the opinion of the investigator, may constitute an unwarranted surgical risk (e.g. severe lung or cardiac disease, unstable medical conditions, anaesthesia allergy, heavy smokers…) 12. Anatomic or physiologic abnormality which could result to significant post-operative complications 13. History of sensitivity to foreign materials or known allergy to any component of the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implant 14. Known alcohol abuse or history of alcohol abuse 15. Psychological instability 16. Underlying disease (HIV-positive, heart failure, renal insufficiency, diabetes, hypertension) 17. Implanted metal or metal devices, history of claustrophobia, or other condition that would make a magnetic resonance imaging (MRI) scan prohibitive 18. Unwilling to undergo any further surgery for revision 19. Unrealistic/unreasonable expectations that entail a risk for the surgical procedure 20. Participating in another clinical study or within exclusion period of a previous clinical study as determined by the investigator 21. Has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study

Locations (6)

Clinique Urbain V Elsan

Avignon, France

Clinique Saint George

Nice, France

Clinique Sainte Geneviève

Paris, France

Clinique Bizet

Paris, France

Clinique du Rond Point des Champs Elysées

Paris, France

Clinique Charcot

Sainte-Foy-lès-Lyon, France

Outcomes

Primary Outcomes

Safety : Incidence of implant and/or procedure-related adverse events/complications

Safety endpoint will be assessed by the incidence of implant and/or procedure-related adverse events/complications at 3 months post implant

Time frame: 3 months post-procedure

Secondary Outcomes

Safety : Incidence of all AEs/SAEs

Safety endpoint will be assessed by the incidence of all AEs/SAEs at 1 year post-procedure

Time frame: 1 year post-procedure

Safety : Incidence of all AEs/SAEs

Safety endpoint will be assessed by the incidence of all AEs/SAEs at 2 years post-procedure

Time frame: 2 years post-procedure

Performance, Implant procedure Success: Surgeon comfort evaluation with procedure duration

Evaluation of surgeon 's satisfaction with procedure duration (5 options: Definitely satisfied, Satisfied, Somewhat satisfied, Somewhat dissatisfied, Definitely dissatisfied)

Time frame: at the implant procedure

Performance, Implant procedure Success: Surgeon comfort evaluation with size incision

Evaluation of surgeon 's satisfaction with size of incision (5 options: Definitely satisfied, Satisfied, Somewhat satisfied, Somewhat dissatisfied, Definitely dissatisfied)

Time frame: at the implant procedure

Performance, Implant procedure Success: Assessment of implant placement and deformation

Assessment of the implant correct placement (absence of visible deformation of the gel) at 3 months

Time frame: 3 months post-procedure

Performance :Surgeon comfort evaluation with comfort level for insertion/implantation of the prothesis

Evaluation of surgeon's satisfaction with the usability of the device during the procedure (current implant procedure), the comfort level for insertion/implantation of the prothesis (5 options: Definitely satisfied, Satisfied, Somewhat satisfied, Somewhat dissatisfied, Definitely dissatisfied)

Time frame: Discharge Visit, an average of 24h

Performance : number of steps of increase in bra cup size

Overall mean number of steps of increase in bra cup size at 3 months, 1 year and 2 years post-procedure