Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtexture… (NCT05336526) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation
France88 participantsStarted 2022-03-18
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Safety : Incidence of implant and/or procedure-related adverse events/complications
✕. 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)