Clinical trial NCT05336526: Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bilateral Breast Augmentation
Lead sponsor: Symatese Aesthetics
Sponsor class: INDUSTRY
First posted: 2022-04-20
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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).


Eligibility criteria: 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

Primary outcomes:
measure: Safety : Incidence of implant and/or procedure-related adverse events/complications
timeFrame: 3 months post-procedure
Secondary outcomes:
measure: Safety : Incidence of all AEs/SAEs
timeFrame: 1 year post-procedure
measure: Safety : Incidence of all AEs/SAEs
timeFrame: 2 years post-procedure
measure: Performance, Implant procedure Success: Surgeon comfort evaluation with procedure duration
timeFrame: at the implant procedure
measure: Performance, Implant procedure Success: Surgeon comfort evaluation with size incision
timeFrame: at the implant procedure
measure: Performance, Implant procedure Success: Assessment of implant placement and deformation
timeFrame: 3 months post-procedure
measure: Performance :Surgeon comfort evaluation with comfort level for insertion/implantation of the prothesis
timeFrame: Discharge Visit, an average of 24h
measure: Performance : number of steps of increase in bra cup size
timeFrame: 3 months, 1 year and 2 years post-procedure
measure: Performance : change in chest circumference at the level of the breasts
timeFrame: 3 months, 1 year and 2 years post-procedure
measure: Performance : satisfaction with the implant size choice
timeFrame: 3 months, 1 year and 2 years post-procedure
measure: Performance : global satisfaction of the patient
timeFrame: 3 months, 1 year and 2 years post-procedure
measure: Performance : global satisfaction of the surgeon
timeFrame: 3 months, 1 year and 2 years post-procedure
Other outcomes:
Locations:
city: Avignon
country: France
facility: Clinique Urbain V Elsan
city: Nice
country: France
facility: Clinique Saint George
city: Paris
country: France
facility: Clinique Sainte Geneviève
city: Paris
country: France
facility: Clinique Bizet
city: Paris
country: France
facility: Clinique du Rond Point des Champs Elysées
city: Sainte-Foy-lès-Lyon
country: France
facility: Clinique Charcot
Study officials:
References: