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

Sponsor

Symatese Aesthetics (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03386682

Collaborator

MedPass International (Industry)

Enrollment

Locations

Arm

36.7

Anticipated Duration (Months)

6.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Augmentation Breast Reconstruction	Device: ESTYME® MATRIX Breast Implants	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 23, 2018

Actual Primary Completion Date :

Apr 15, 2019

Anticipated Study Completion Date :

Apr 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ESTYME MATRIX Participants who meet the requirements for breast augmentation or breast reconstruction surgeries and have been implanted with one or two ESTYME® MATRIX Breast Implant(s)	Device: ESTYME® MATRIX Breast Implants Breast implant surgery in breast reconstruction or breast augmentation

Arm

Intervention/Treatment

Experimental: ESTYME MATRIX

Participants who meet the requirements for breast augmentation or breast reconstruction surgeries and have been implanted with one or two ESTYME® MATRIX Breast Implant(s)

Device: ESTYME® MATRIX Breast Implants

Breast implant surgery in breast reconstruction or breast augmentation

Outcome Measures

Primary Outcome Measures

Local complications [3 months]
Evaluation of the safety 3 months post-implantation. Procedure-related adverse events/complications at 3 months post implant. Main foreseen complications: infection, haematoma, wound healing complication, fluid accumulation, early capsular contracture, rupture, extrusion.
Satisfaction of the patient and the surgeon [3 months]
Evaluation of the performance, 3 months post-implantation Performance endpoint will be assessed by implant procedure success at 3 months defined as follows: satisfactory procedure duration for the surgeon satisfactory size of the incision for the surgeon implant correct placement (absence of visible deformation of the gel, absence of rotation for anatomical implants)

Secondary Outcome Measures

Local complications [1 year and 2 years]
Evaluation of the safety, 1 year and two years post-implantation. Safety endpoint: incidence of all Adverse Events (AE)/Serious Adverse Events (SAEs) @ 1 year and two years post procedure
Satisfaction of the patient and the surgeon [1 year and 2 years]
Performance endpoints are as follows: global surgeon satisfaction post-procedure assessed by the usability of the device during the procedure (current implant procedure): surgeon comfort level for the insertion/implantation of the prosthesis, global patient and surgeon satisfaction @ 1 year and 2 years post-procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patient will be included if all of the following criteria are met:

Subject of between 18 and 65 years old
Candidate eligible for :

unilateral or bilateral breast augmentation i. general breast enlargement: cosmetic purposes, providing symmetry to opposite breast in case of unilateral surgery ii. surgical correction of various congenital or acquired anomalies such as amastia, aplasia, hypomastia, hypoplasia, asymmetries, Poland's syndrome, ptosis …
or immediate or delayed unilateral or bilateral breast reconstruction (for cancer, trauma, surgical loss of breast)

Patient signs PIC (Patient Informed Consent) & willing to comply with the protocol assessments and visits follow up

Exclusion Criteria:

Patient will not be included if any of the following conditions exists:

Local or systemic infection or abscess anywhere in the body
Existing carcinoma or pre-carcinoma of the breast without treatment or mastectomy treatment without appropriate wash out period for chemotherapy at the surgeon discretion
Subject with previous tissue expansion
Diagnosis of active cancer of any type for augmentation procedure subject
Pregnant subject or intending to become pregnant within three (3) months of the implant procedure
Subject who had nursed within three (3) months of implant surgery, or still breastfeeding
Tissue characteristics determined clinically inadequate or unsuitable by the surgeon (i.e. tissue damage resulting from radiation, inadequate tissue or compromised vascularity, know complication wound healing)
Previously implanted subject with a silicone implant or History of failure following cosmetic augmentation or subcutaneous mastectomy
History of autoimmune disease such as but not limited to: lupus, scleroderma …
Any condition or treatment for any condition which, in the opinion of the physician, may constitute an unwarranted surgical risk (e.g. anaesthesia allergy, high consumption smoking subject …)
Anatomic or physiologic abnormality which could result to significant post-operative complications
History of sensitivity of foreign materials or known allergy to any component of the ESTYME® MATRIX Silicone Gel-Filled Breast Implant
Subject known for alcohol abuse/history
Underlying disease (HIV positive Subject, HF (heart Failure), renal insufficiency, diabetes, hypertension, …)
Subject with implanted metal or metal devices, history of claustrophobia, or other condition that would make a MRI scan prohibitive
Unwilling to undergo any further surgery for revision
Subject with willingness that are unrealistic/unreasonable with the risks involved with the surgical procedure
Participating into any other clinical study or had participated into a clinical study without appropriate wash out period at the surgeon discretion
Subject who has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre F.X. Michelet Chu Bordeaux	Bordeaux	France	33076
2	Chu Pasteur	Nice	France	06000
3	Clinique des Champs Elysées	Paris	France	75008
4	Clinique BIZET	Paris	France	75016
5	Institut du Sein	Paris	France	75017
6	Hopital Tenon	Paris	France	75020
7	Clinique Charcot	Sainte-Foy-lès-Lyon	France	69500
8	Institut Gustave Roussy	Villejuif	France	94805

Sponsors and Collaborators

Symatese Aesthetics
MedPass International

Investigators

Principal Investigator: EMMANUEL DELAY, MD, Clinique Charcot

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Symatese Aesthetics

ClinicalTrials.gov Identifier:

NCT03386682

Other Study ID Numbers:

Protocol CLIN PMI-002

First Posted:

Dec 29, 2017

Last Update Posted:

Apr 8, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 8, 2021