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

Sponsor

Euromi Biosciences (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05987475

Collaborator

(none)

177

Enrollment

Location

132

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Implant Rupture Breast Implant; Complications	Procedure: Breast reconstruction

Study Design

Study Type:

Observational

Anticipated Enrollment :

177 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2034

Anticipated Study Completion Date :

Sep 1, 2034

Outcome Measures

Primary Outcome Measures

Rate of capsular contracture [From implantation to end of study (10-year)]
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).
Post-surgery rupture [From implantation to end of study (10-year)]
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).

Secondary Outcome Measures

Participant's QoL [From implantation to end of study (10-year)]
Quality of life: will be evaluated using the French version of the Breast Body Image Scale (BBIS).
Breast implant survival rate. [From implantation to end of study (10-year)]
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.
Frequency of occurrence of other adverse events and complications [From implantation to end of study (10-year)]
Evaluate the frequency of occurrence of other adverse events and complications recorded during the study
Participant's and investigator's satisfaction regarding the aesthetic result [From implantation to end of study (10-year)]
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.
Reoperation rate [From implantation to end of study (10-year)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU Nancy	Nancy		France

Sponsors and Collaborators

Euromi Biosciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Euromi Biosciences

ClinicalTrials.gov Identifier:

NCT05987475

Other Study ID Numbers:

ID RCB: 2023-A00101-44

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rupture

Study Results

No Results Posted as of Aug 14, 2023