Informations générales (source: ClinicalTrials.gov)
Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation, Primary Intention (EMMA Study) (EMMA)
Interventional
N/A
Symatese Aesthetics (Voir sur ClinicalTrials)
mars 2022
septembre 2025
26 juin 2024
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).
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Clinique Bizet - 75016 - Paris - France | Contact (sur clinicalTrials) | ||||
| Clinique Charcot - 69110 - Sainte-Foy-lès-Lyon - France | Contact (sur clinicalTrials) | ||||
| Clinique du Rond Point des Champs Elysées - 75016 - Paris - France | Contact (sur clinicalTrials) | ||||
| Clinique Saint George - 06105 - Nice - France | Contact (sur clinicalTrials) | ||||
| Clinique Sainte Geneviève - 75014 - Paris - France | Contact (sur clinicalTrials) | ||||
| Clinique Urbain V Elsan - 84000 - Avignon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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