NCT03386682

Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Symatese Aesthetics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.

Detailed description

The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction at 3 months, 1 year and 2 years post-procedure

Conditions

• Breast Augmentation
• Breast Reconstruction

Interventions

Type	Name	Description
DEVICE	ESTYME® MATRIX Breast Implants	Breast implant surgery in breast reconstruction or breast augmentation

Timeline

• Start date: 2018-03-23
• Primary completion: 2019-04-15
• Completion: 2021-04-12
• First posted: 2017-12-29
• Last updated: 2021-04-08

Locations

8 sites across 1 country: France