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

  • STATUS
    Recruiting
  • End date
    Aug 28, 2024
  • participants needed
    88
  • sponsor
    Symatese Aesthetics
Updated on 28 April 2022
Accepts healthy volunteers

Summary

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).

Details
Condition Bilateral Breast Augmentation
Treatment ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants
Clinical Study IdentifierNCT05336526
SponsorSymatese Aesthetics
Last Modified on28 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged between 18 and 65 years
Eligible for bilateral breast augmentation in primary intention
general breast enlargement for cosmetic purposes
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)
Signature of Patient Information Consent (PIC) & willingness to comply with the
protocol assessments and follow up visits
Affiliation to the social security regime

Exclusion Criteria

Local or systemic infection or abscess anywhere in the body
Existing carcinoma or pre-carcinoma of the breast with or without treatment
History of subcutaneous mastectomy
Subject with previous tissue expansion
Diagnosis of active cancer of any type
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)
Has breastfed within three (3) months the implant surgery, or is still breastfeeding
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)
Has been previously implanted with a silicone implant or history of failure following cosmetic augmentation
History of autoimmune disease such as, but not limited to, lupus and scleroderma
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…)
Anatomic or physiologic abnormality which could result to significant post-operative complications
History of sensitivity to foreign materials or known allergy to any component of the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implant
Known alcohol abuse or history of alcohol abuse
Psychological instability
Underlying disease (HIV-positive, heart failure, renal insufficiency, diabetes, hypertension)
Implanted metal or metal devices, history of claustrophobia, or other condition that would make a magnetic resonance imaging (MRI) scan prohibitive
Unwilling to undergo any further surgery for revision
Unrealistic/unreasonable expectations that entail a risk for the surgical procedure
Participating in another clinical study or within exclusion period of a previous clinical study as determined by the investigator
Has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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