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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Implant Rupture; Breast Implant; Complications
• Intervention / Treatment: Procedure: Breast reconstruction

• Study Type: Observational
• Enrollment (Estimated): 177

Contacts and Locations

Study Locations

• France
  • Nancy, France
    • Recruiting
    • CHRU Nancy
    • Contact: CHRU Nancy; Phone Number: +33 3 83 85 85 85; Email: communication@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Euromi Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): September 1, 2034

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: ID RCB: 2023-A00101-44

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No