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

NCT03386682 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-04-08

No results posted yet for this study

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.

Conditions

  • Breast Augmentation
  • Breast Reconstruction

Interventions

DEVICE

ESTYME® MATRIX Breast Implants

Breast implant surgery in breast reconstruction or breast augmentation

Sponsors & Collaborators

  • MedPass International

    collaborator INDUSTRY

  • Symatese Aesthetics

    lead INDUSTRY

Principal Investigators

  • EMMANUEL DELAY, MD · Clinique Charcot

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-23
Primary Completion
2019-04-15
Completion
2021-04-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386682 on ClinicalTrials.gov