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

NCT ID: NCT05987475

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 177 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2034-09-30

Brief Summary

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

Conditions

Breast Implant Rupture; Breast Implant; Complications

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Breast augmentation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Euromi Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU Nancy

Nancy, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

CHRU Nancy

Role: primary

Other Identifiers

ID RCB: 2023-A00101-44

Identifier Type: -

Identifier Source: org_study_id