UnknownNot Applicable

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

France50 participantsStarted 2018-03-23

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Subject of between 18 and 65 years old
✓. Candidate eligible for :
✓. Patient signs PIC (Patient Informed Consent) \& willing to comply with the protocol assessments and visits follow up

Exclusion criteria

✕. 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

What they're measuring

Local complications

Timeframe: 3 months

Satisfaction of the patient and the surgeon

Timeframe: 3 months

Trial details

NCT IDNCT03386682

SponsorSymatese Aesthetics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-15

View on ClinicalTrials.gov More Breast Augmentation trials