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Recruiting NCT05987475

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

— Observational Breast Implant Rupture Breast Implant; Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Breast reconstruction.
Who it may be relevant to
Registry conditions: Breast Implant Rupture, Breast Implant; Complications. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • 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

Primary outcome measures

  • Rate of capsular contracture [Time frame: From implantation to end of study (10-year)]
  • Post-surgery rupture [Time frame: From implantation to end of study (10-year)]
Secondary outcome measures (5)
  • Participant's QoL [Time frame: From implantation to end of study (10-year)]
  • Breast implant survival rate. [Time frame: From implantation to end of study (10-year)]
  • Frequency of occurrence of other adverse events and complications [Time frame: From implantation to end of study (10-year)]
  • Participant's and investigator's satisfaction regarding the aesthetic result [Time frame: From implantation to end of study (10-year)]
  • Reoperation rate [Time frame: From implantation to end of study (10-year)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

France · 1 center
  • CHRU Nancy — Nancy

Identifiers

NCT: NCT05987475 · ID RCB: 2023-A00101-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗