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

NCT05336526 | Active Not Recruiting DMC

• 1 other identifier: CLIN PMI-004
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Safety : Incidence of implant and/or procedure-related adverse events/complications

  Safety endpoint will be assessed by the incidence of implant and/or procedure-related adverse events/complications at 3 months post implant

  3 months post-procedure

Secondary Outcomes (11)

• Safety : Incidence of all AEs/SAEs

  1 year post-procedure

• Safety : Incidence of all AEs/SAEs

  2 years post-procedure

• Performance, Implant procedure Success: Surgeon comfort evaluation with procedure duration

  at the implant procedure

• Performance, Implant procedure Success: Surgeon comfort evaluation with size incision

  at the implant procedure

• Performance, Implant procedure Success: Assessment of implant placement and deformation

  3 months post-procedure

Study Arms (1)

ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants

EXPERIMENTAL

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

Device: ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants

Interventions

ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants DEVICE

Bilateral brest augmentation in primary intention

ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Symatese Aesthetics: lead

Study Sites (6)

Clinique Urbain V Elsan

Avignon, 84000, France

Location

Clinique Saint George

Nice, 06105, France

Location

Clinique Sainte Geneviève

Paris, 75014, France

Location

Clinique Bizet

Paris, 75016, France

Location

Clinique du Rond Point des Champs Elysées

Paris, 75016, France

Location

Clinique Charcot

Sainte-Foy-lès-Lyon, 69110, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 20, 2022
• Study Start: March 18, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)