Status:
UNKNOWN
Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study
Lead Sponsor:
Symatese Aesthetics
Collaborating Sponsors:
MedPass International
Conditions:
Breast Augmentation
Breast Reconstruction
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 12 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03386682
Start Date
March 23 2018
End Date
April 12 2021
Last Update
April 8 2021
Active Locations (8)
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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