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

NCT03386682 | Unknown

• 1 other identifier: Protocol CLIN PMI-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 8

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.

Conditions

Breast Augmentation; Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

• Local complications

  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.

  3 months

• Satisfaction of the patient and the surgeon

  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)

  3 months

Secondary Outcomes (2)

• Local complications

  1 year and 2 years

• Satisfaction of the patient and the surgeon

  1 year and 2 years

Study Arms (1)

ESTYME MATRIX

EXPERIMENTAL

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

Interventions

ESTYME® MATRIX Breast Implants DEVICE

Breast implant surgery in breast reconstruction or breast augmentation

ESTYME MATRIX

Eligibility Criteria

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

You may qualify if:

• Patient will be included if all of the following criteria are met:
• Subject of between 18 and 65 years old
• Candidate eligible for :
• a. 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 …
• b. 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

You may not qualify if:

• 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, …)

Sponsors & Collaborators

• Symatese Aesthetics: lead
• MedPass International: collaborator

Study Sites (8)

Centre F.X. Michelet Chu Bordeaux

Bordeaux, 33076, France

Location

Chu Pasteur

Nice, 06000, France

Location

Clinique des Champs Elysées

Paris, 75008, France

Location

Clinique BIZET

Paris, 75016, France

Location

Institut du Sein

Paris, 75017, France

Location

Hopital Tenon

Paris, 75020, France

Location

Clinique Charcot

Sainte-Foy-lès-Lyon, 69500, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Study Officials

• EMMANUEL DELAY, MD

  Clinique Charcot

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 29, 2017
• Study Start: March 23, 2018
• Primary Completion: April 15, 2019
• Study Completion: April 12, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)