Status:
ACTIVE_NOT_RECRUITING
Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation
Lead Sponsor:
Symatese Aesthetics
Conditions:
Bilateral Breast Augmentation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 imp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05336526
Start Date
March 18 2022
End Date
September 1 2025
Last Update
June 25 2024
Active Locations (6)
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1
Clinique Urbain V Elsan
Avignon, France, 84000
2
Clinique Saint George
Nice, France, 06105
3
Clinique Sainte Geneviève
Paris, France, 75014
4
Clinique Bizet
Paris, France, 75016