Clinical trial NCT03386682: Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Augmentation
Breast Reconstruction
Lead sponsor: Symatese Aesthetics
Sponsor class: INDUSTRY
Collaborators: name: MedPass International
First posted: 2017-12-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Local complications
timeFrame: 3 months
measure: Satisfaction of the patient and the surgeon
timeFrame: 3 months
Secondary outcomes:
measure: Local complications
timeFrame: 1 year and 2 years
measure: Satisfaction of the patient and the surgeon
timeFrame: 1 year and 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre F.X. Michelet Chu Bordeaux
city: Nice
country: France
facility: Chu Pasteur
city: Paris
country: France
facility: Clinique des Champs Elysées
city: Paris
country: France
facility: Clinique BIZET
city: Paris
country: France
facility: Institut du Sein
city: Paris
country: France
facility: Hopital Tenon
city: Sainte-Foy-lès-Lyon
country: France
facility: Clinique Charcot
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Clinique Charcot
name: EMMANUEL DELAY, MD
role: PRINCIPAL_INVESTIGATOR
References: