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
This trial accepts healthy volunteersQualifiers
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 population
Two groups of participants will be distinguished: * Group 1: Insertion of an implant in the event of a breast augmentation (for aesthetic reasons) * Group 2: Insertion of an implant in the event of a breast reconstruction (eg.. following breast cancer)
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Breast reconstruction
Procedure/SurgeryBreast reconstruction and breast augmentation based on the indications as listed out in the instructions for use of the medical device under investigation
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Rate of capsular contracture
To describe the rate of capsular contracture. Capsular contracture will be evaluated according to the Baker classification (from I to IV with grade III/IV considered as retractile capsular contractures).
Time frame
From implantation to end of study (10-year)2
Post-surgery rupture
To describe the rate of post-surgery rupture. Rupture will be evaluated based on cases of hardening or deflation, based on clinical signs and if deemed necessary by the investigator, by medical imaging (mammography, ultrasound, MRI).
Time frame
From implantation to end of study (10-year)Secondary outcomes
1
Participant's QoL
Quality of life: will be evaluated using the French version of the Breast Body Image Scale (BBIS).
Time frame
From implantation to end of study (10-year)2
Breast implant survival rate.
Breast implant survival rate: the event will be defined as the removal of a breast implant for any reason other than participant's wish. Breast survival will be defined as the absence of breast implant removal. The analysis will be at the implant level and at the participant level, overall and by group.
Time frame
From implantation to end of study (10-year)3
Frequency of occurrence of other adverse events and complications
Evaluate the frequency of occurrence of other adverse events and complications recorded during the study
Time frame
From implantation to end of study (10-year)4
Participant's and investigator's satisfaction regarding the aesthetic result
Participant and investigator satisfaction with aesthetic results: questionnaire using generic 6-level Likert scale: extremely dissatisfied, very dissatisfied, somewhat dissatisfied, somewhat satisfied, very satisfied, extremely satisfied.
Time frame
From implantation to end of study (10-year)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov