NCT05336526

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

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Symatese Aesthetics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants	Bilateral brest augmentation in primary intention

Timeline

• Start date: 2022-03-18
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-04-20
• Last updated: 2024-06-25

Locations

6 sites across 1 country: France