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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective observational follow-up study to monitor the outcomes of breast reconstruction and augmentation using Euromi Biosciences pre-filled silicone gel breast implants. This study aims to collect long-term safety and performance data over a 10-year period, focusing on complications such as implant rupture and capsular contracture in female participants aged 18 to under 60 years. The study observes participants who have received at least one Euromi Biosciences silicone gel implant during breast reconstruction after mastectomy or for aesthetic breast surgery. There is no intervention or treatment assigned by the study; rather, it follows participants naturally after their implant procedure to evaluate outcomes and any related events. During participation, individuals are monitored for the rate of capsular contracture, post-surgery rupture, implant survival, frequency of adverse events, quality of life, satisfaction with aesthetic results, and reoperation rates. Follow-up extends up to 10 years post-implantation, with ongoing assessments to gather comprehensive data on implant performance and participant wellbeing throughout this period.
CONDITIONS
Brief 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
- 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
- Willing to be followed up for a period of 10 years
You will not qualify if you...
- Pregnant or breastfeeding at the time of inclusion
- Known hypersensitivity and/or allergy to silicone
- Does not understand or accept the risks of further surgeries during follow-up
- Body mass index greater than 40 kg/m�b2
- Diabetes or HbA1c levels greater than 7.5%
- History of repeated failure with similar implants
- Tissue or fat insufficiency
- Progressive breast cancer with large tumors (>5 cm), late cancer stage, or deep tumors
- Grossly positive axillary or chest wall involvement
- High risk of cancer recurrence
- Tissue damage in the implant area from thoracic wall irradiation
- Pre-existing pathology in the implant area
- General infection or infection in the implant area
- Medical conditions posing excessive risk or post-surgical complications as judged by the surgeon
- History or presence of autoimmune disease
- Immunocompromised condition
- History or current treatment involving radiation with lower-pole scarring, thin or poorly vascularized skin/tissue, microwave diathermy, or steroids
- Medical condition interfering with understanding or participation in follow-up
- Currently part of another interventional clinical trial
- Under legal guardianship or supervision
- Deprived of liberty by judicial or administrative decision
- Not affiliated with a health insurance system or coverage beneficiary
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo breast reconstruction or augmentation with Euromi Biosciences pre-filled silicone gel breast implants as part of routine healthcare.
1 visit (in-person)
Duration - Up to 10 years
Participants are followed up to monitor implant safety, complications, and satisfaction over a 10-year period after implantation.
Regular follow-up visits during 10 years
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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