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

Not Applicable
Conditions
Breast Augmentation
Breast Reconstruction
Interventions
Device: ESTYME® MATRIX Breast Implants
Registration Number
NCT03386682
Lead Sponsor
Symatese Aesthetics
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.

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

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
Inclusion Criteria

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

  1. Subject of between 18 and 65 years old

  2. 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)

  3. 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:

  1. Local or systemic infection or abscess anywhere in the body
  2. Existing carcinoma or pre-carcinoma of the breast without treatment or mastectomy treatment without appropriate wash out period for chemotherapy at the surgeon discretion
  3. Subject with previous tissue expansion
  4. Diagnosis of active cancer of any type for augmentation procedure subject
  5. Pregnant subject or intending to become pregnant within three (3) months of the implant procedure
  6. Subject who had nursed within three (3) months of implant surgery, or still breastfeeding
  7. 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)
  8. Previously implanted subject with a silicone implant or History of failure following cosmetic augmentation or subcutaneous mastectomy
  9. History of autoimmune disease such as but not limited to: lupus, scleroderma ...
  10. 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 ...)
  11. Anatomic or physiologic abnormality which could result to significant post-operative complications
  12. History of sensitivity of foreign materials or known allergy to any component of the ESTYME® MATRIX Silicone Gel-Filled Breast Implant
  13. Subject known for alcohol abuse/history
  14. Underlying disease (HIV positive Subject, HF (heart Failure), renal insufficiency, diabetes, hypertension, ...)
  15. Subject with implanted metal or metal devices, history of claustrophobia, or other condition that would make a MRI scan prohibitive
  16. Unwilling to undergo any further surgery for revision
  17. Subject with willingness that are unrealistic/unreasonable with the risks involved with the surgical procedure
  18. Participating into any other clinical study or had participated into a clinical study without appropriate wash out period at the surgeon discretion
  19. Subject who has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ESTYME MATRIXESTYME® MATRIX Breast ImplantsParticipants who meet the requirements for breast augmentation or breast reconstruction surgeries and have been implanted with one or two ESTYME® MATRIX Breast Implant(s)
Primary Outcome Measures
NameTimeMethod
Local complications3 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 surgeon3 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
NameTimeMethod
Local complications1 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 surgeon1 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

Trial Locations

Locations (8)

Centre F.X. Michelet Chu Bordeaux

🇫🇷

Bordeaux, France

Chu Pasteur

🇫🇷

Nice, France

Clinique des Champs Elysées

🇫🇷

Paris, France

Clinique BIZET

🇫🇷

Paris, France

Institut du Sein

🇫🇷

Paris, France

Hopital Tenon

🇫🇷

Paris, France

Clinique Charcot

🇫🇷

Sainte-Foy-lès-Lyon, France

Institut Gustave Roussy

🇫🇷

Villejuif, France

Centre F.X. Michelet Chu Bordeaux
🇫🇷Bordeaux, France
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