Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-60
SponsorEuromi Biosciences
About this trial
Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT
Eligibility criteria
Qualifiers
Female;
18 years old and above, and under 60 years old;
has approved and signed the informed consent form;
eligible to receive at least one EUROMI Biosciences implant during breast reconstruction following a mastectomy or during aesthetic breast surgery;
Disqualifiers
Informed pregnancy or breastfeeding at the time of inclusion
Known hypersensitivity and / or allergy to silicone;
Not understanding or not accepting the risks of further surgeries during follow-up;
Body mass index > 40 kg/m²;
Trial design
Treatments tested in this trial
- Breast reconstruction
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov