Actively Recruiting
Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
Led by Euromi Biosciences · Updated on 2023-11-29
177
Participants Needed
1
Research Sites
567 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT
CONDITIONS
Official Title
Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Between 18 years old and under 60 years old
- Signed informed consent form
- Eligible to receive at least one Euromi Biosciences implant during breast reconstruction after mastectomy or aesthetic breast surgery
- Willing to be followed up for 10 years
You will not qualify if you...
- Pregnant or breastfeeding at the time of inclusion
- Known allergy or hypersensitivity to silicone
- Does not understand or accept risks of further surgeries during follow-up
- Body mass index over 40 kg/m²
- Diabetes or HbA1c levels above 7.5%
- History of repeated failure with similar implants
- Tissue or fat insufficiency
- Progressive breast cancer with large tumors over 5 cm, late stage, or deep tumors
- Grossly positive axillary or chest wall involvement
- High risk of cancer recurrence
- Tissue damage in implant area from thoracic wall irradiation
- Pre-existing pathology in implant area
- General or implant area infection
- Medical conditions increasing surgical risk or complications (including poor health, psychological instability, severe smoking, obesity, coagulopathy, severe cardiovascular or pulmonary disease)
- History or presence of autoimmune disease
- Immunocompromised status
- History or current treatment involving radiation with scarring or thin, poorly vascularized skin/tissue, microwave diathermy, or steroids
- Medical condition affecting ability to understand or participate in follow-up or give informed consent
- Participation in another interventional clinical trial
- Under legal supervision or guardianship
- Deprived of liberty by judicial or administrative decision
- Not covered by health insurance or beneficiary of such coverage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHRU Nancy
Nancy, France
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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