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

NCT ID: NCT05336526

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-18
• Study Completion Date: 2025-09-30

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).

Conditions

Bilateral Breast Augmentation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants

Participants who meet the requirements for bilateral breast augmentation in primary intention and have been implanted with ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants

Group Type: EXPERIMENTAL

ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants

Intervention Type: DEVICE

Bilateral brest augmentation in primary intention

Interventions

ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants

Bilateral brest augmentation in primary intention

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Symatese Aesthetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Urbain V Elsan

Avignon, , France

Clinique Saint George

Nice, , France

Clinique Sainte Geneviève

Paris, , France

Clinique Bizet

Paris, , France

Clinique du Rond Point des Champs Elysées

Paris, , France

Clinique Charcot

Sainte-Foy-lès-Lyon, , France

Countries

France

Other Identifiers

CLIN PMI-004

Identifier Type: -

Identifier Source: org_study_id