xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05987475</url>
    </required_header>
    <id_info>
      <org_study_id>ID RCB: 2023-A00101-44</org_study_id>
      <nct_id>NCT05987475</nct_id>
    </id_info>
    <brief_title>Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants</brief_title>
    <acronym>ELEGANT</acronym>
    <official_title>Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Euromi Biosciences</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Euromi Biosciences</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast&#xD;
        implants - Post-market clinical investigation - ELEGANT&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2034</completion_date>
    <primary_completion_date type="Anticipated">September 2034</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of capsular contracture</measure>
      <time_frame>From implantation to end of study (10-year)</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Post-surgery rupture</measure>
      <time_frame>From implantation to end of study (10-year)</time_frame>
      <description>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).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Participant's QoL</measure>
      <time_frame>From implantation to end of study (10-year)</time_frame>
      <description>Quality of life: will be evaluated using the French version of the Breast Body Image Scale (BBIS).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Breast implant survival rate.</measure>
      <time_frame>From implantation to end of study (10-year)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of occurrence of other adverse events and complications</measure>
      <time_frame>From implantation to end of study (10-year)</time_frame>
      <description>Evaluate the frequency of occurrence of other adverse events and complications recorded during the study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant's and investigator's satisfaction regarding the aesthetic result</measure>
      <time_frame>From implantation to end of study (10-year)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reoperation rate</measure>
      <time_frame>From implantation to end of study (10-year)</time_frame>
      <description>Reoperation will be defined as a new operation at the breast implant site for any cause.&#xD;
  The analyses will be performed at the implant level and at the participant level, overall and by group</description>
    </secondary_outcome>
    <enrollment type="Anticipated">177</enrollment>
    <condition>Breast Implant Rupture</condition>
    <condition>Breast Implant; Complications</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Breast reconstruction</intervention_name>
      <description>Breast reconstruction and breast augmentation based on the indications as listed out in the instructions for use of the medical device under investigation</description>
      <other_name>Breast augmentation</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Two groups of participants will be distinguished:&#xD;
  &#xD;
            -  Group 1: Insertion of an implant in the event of a breast augmentation (for aesthetic&#xD;
               reasons)&#xD;
  &#xD;
            -  Group 2: Insertion of an implant in the event of a breast reconstruction (eg..&#xD;
               following breast cancer)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female;&#xD;
  &#xD;
            -  18 years old and above, and under 60 years old;&#xD;
  &#xD;
            -  has approved and signed the informed consent form;&#xD;
  &#xD;
            -  eligible to receive at least one EUROMI Biosciences implant during breast&#xD;
               reconstruction following a mastectomy or during aesthetic breast surgery;&#xD;
  &#xD;
            -  Willing to be followed up for a period of 10 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Informed pregnancy or breastfeeding at the time of inclusion&#xD;
  &#xD;
            -  Known hypersensitivity and / or allergy to silicone;&#xD;
  &#xD;
            -  Not understanding or not accepting the risks of further surgeries during follow-up;&#xD;
  &#xD;
            -  Body mass index &gt; 40 kg/m²;&#xD;
  &#xD;
            -  Diabetes&#xD;
  &#xD;
            -  HbA1c levels &gt; 7,5%;&#xD;
  &#xD;
            -  History of repeated failure with the implantation of similar implants;&#xD;
  &#xD;
            -  Tissue or fat insufficiency;&#xD;
  &#xD;
            -  Progressive breast cancer large tumours (&gt;5 cm), late cancer stage and deep tumours;&#xD;
  &#xD;
            -  Grossly positive axillary involvement / or chest wall involvement;&#xD;
  &#xD;
            -  High risk of cancer recurrence;&#xD;
  &#xD;
            -  Tissue damage in the implant area due to irradiation of the thoracic wall;&#xD;
  &#xD;
            -  Pre-existing pathology in the implant area;&#xD;
  &#xD;
            -  General infection or infection in the implant area;&#xD;
  &#xD;
            -  Medical condition (poor physiological condition, psychological instability, severe&#xD;
               smoking, obesity, coagulopathy, diabetes, severe cardiovascular or pulmonary disease,&#xD;
               etc.) Which may, according to the judgement of the surgeon, entail excessive risk&#xD;
               and/or post-surgical complications;&#xD;
  &#xD;
            -  History or presence of an autoimmune disease;&#xD;
  &#xD;
            -  Immunocompromised;&#xD;
  &#xD;
            -  History or current treatment using radiation with lower-pole scarring and thin, poorly&#xD;
               vascularized skin/tissue / microwave diathermy / or steroids;&#xD;
  &#xD;
            -  Medical condition likely to interfere with her capacity to understand the follow-up&#xD;
               requirements, to participate in the follow-up or to give her informed consent;&#xD;
  &#xD;
            -  Concomitantly part of another interventional clinical trial.&#xD;
  &#xD;
            -  Under supervision or legal guardianship&#xD;
  &#xD;
            -  Deprived of liberty by a judicial or administrative decision&#xD;
  &#xD;
            -  Not affiliated to health insurance system or is a beneficiary of such coverage&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>CHRU Nancy</name>
        <address>
          <city>Nancy</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>CHRU Nancy</last_name>
        <phone>+33 3 83 85 85 85</phone>
        <email>communication@chru-nancy.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rupture</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05987475
  org study id: ID RCB: 2023-A00101-44
  nct id: NCT05987475
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast
        implants - Post-market clinical investigation - ELEGANT
  observational model: Other
  time perspective: Prospective
  measure: Rate of capsular contracture
  time frame: From implantation to end of study (10-year)
  description: 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).
  measure: Post-surgery rupture
  time frame: From implantation to end of study (10-year)
  description: 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).
  measure: Participant's QoL
  time frame: From implantation to end of study (10-year)
  description: Quality of life: will be evaluated using the French version of the Breast Body Image Scale (BBIS).
  measure: Breast implant survival rate.
  time frame: From implantation to end of study (10-year)
  description: 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.
  measure: Frequency of occurrence of other adverse events and complications
  time frame: From implantation to end of study (10-year)
  description: Evaluate the frequency of occurrence of other adverse events and complications recorded during the study
  measure: Participant's and investigator's satisfaction regarding the aesthetic result
  time frame: From implantation to end of study (10-year)
  description: 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.
  measure: Reoperation rate
  time frame: From implantation to end of study (10-year)
  description: 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
  intervention type: Procedure
  intervention name: Breast reconstruction
  description: Breast reconstruction and breast augmentation based on the indications as listed out in the instructions for use of the medical device under investigation
  other name: Breast augmentation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Rupture