Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants

Breast Implant; Complications Clinical Trial

— ELEGANT  

Official title:

Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987475
• Other study ID #: ID RCB: 2023-A00101-44
• Status: Recruiting
• Start date: October 18, 2023
• Est. completion date: September 2034

Study information

• Verified date: November 2023
• Source: Euromi Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 177
• Est. completion date: September 2034
• Est. primary completion date: September 2034
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• Diabetes

• HbA1c levels > 7,5%;

• History of repeated failure with the implantation of similar implants;

• Tissue or fat insufficiency;

• Progressive breast cancer large tumours (>5 cm), late cancer stage and deep tumours;

• Grossly positive axillary involvement / or chest wall involvement;

• High risk of cancer recurrence;

• Tissue damage in the implant area due to irradiation of the thoracic wall;

• Pre-existing pathology in the implant area;

• General infection or infection in the implant area;

• Medical condition (poor physiological condition, psychological instability, severe smoking, obesity, coagulopathy, diabetes, severe cardiovascular or pulmonary disease, etc.) Which may, according to the judgement of the surgeon, entail excessive risk and/or post-surgical complications;

• History or presence of an autoimmune disease;

• Immunocompromised;

• History or current treatment using radiation with lower-pole scarring and thin, poorly vascularized skin/tissue / microwave diathermy / or steroids;

• Medical condition likely to interfere with her capacity to understand the follow-up requirements, to participate in the follow-up or to give her informed consent;

• Concomitantly part of another interventional clinical trial.

• Under supervision or legal guardianship

• Deprived of liberty by a judicial or administrative decision

• Not affiliated to health insurance system or is a beneficiary of such coverage

Related Conditions & MeSH terms

• Breast Implant Rupture
• Breast Implant; Complications
• Rupture

Intervention

Procedure:
• Breast reconstruction
Breast reconstruction and breast augmentation based on the indications as listed out in the instructions for use of the medical device under investigation

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Euromi Biosciences

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	From implantation to end of study (10-year)
Primary	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).	From implantation to end of study (10-year)
Secondary	Participant's QoL	Quality of life: will be evaluated using the French version of the Breast Body Image Scale (BBIS).	From implantation to end of study (10-year)
Secondary	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.	From implantation to end of study (10-year)
Secondary	Frequency of occurrence of other adverse events and complications	Evaluate the frequency of occurrence of other adverse events and complications recorded during the study	From implantation to end of study (10-year)
Secondary	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.	From implantation to end of study (10-year)
Secondary	Reoperation rate	Reoperation will be defined as a new operation at the breast implant site for any cause.; The analyses will be performed at the implant level and at the participant level, overall and by group	From implantation to end of study (10-year)