<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/NCT02206282</url>
  </required_header>
  <id_info>
    <org_study_id>IMR-LT-001</org_study_id>
    <nct_id>NCT02206282</nct_id>
  </id_info>
  <brief_title>Prevalence of Asymptomatic Rupture in SILIMED Breast Implants</brief_title>
  <official_title>Prevalence of Asymptomatic Rupture in SILIMED Breast Implants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Silimed Industria de Implantes Ltda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Silimed Industria de Implantes Ltda</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective clinical research is to assess the prevalence of implant rupture and presence&#xD;
      of extracapsular gel in an un-referred population of women who have been implanted with the&#xD;
      Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2006</start_date>
  <completion_date type="Actual">February 2011</completion_date>
  <primary_completion_date type="Actual">November 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Magnetic Resonance Image</measure>
    <time_frame>1 year</time_frame>
    <description>390 Magnetic Resonance Images.</description>
  </primary_outcome>
  <enrollment type="Actual">390</enrollment>
  <condition>Breast Implant Rupture</condition>
  <eligibility>
    <study_pop>
      <textblock>
        390 women (780 implants) from Rio de Janeiro and other Brazilian cities will be randomly&#xD;
        selected to undergo MRI detection of asymptomatic rupture using a stratified sampling&#xD;
        design, stratifying on implant age (time since implantation). Sixty-five (65) women will be&#xD;
        selected from each of six implant age groups between 6-18 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Subject implanted with the original Silimed gel-filled implant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MR imaging is not possible because of the following:&#xD;
&#xD;
          -  Metal implant&#xD;
&#xD;
          -  Battery activated stimulator&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Tattoos&#xD;
&#xD;
          -  Body weight &gt;300 pounds&#xD;
&#xD;
          -  History of metal fragments in the eye&#xD;
&#xD;
          -  Any other contraindication to MR exam.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wanda Elizabeth Massiere Correa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Insituto Ivo Pitanguy</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 30, 2014</last_update_submitted>
  <last_update_submitted_qc>July 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2014</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>


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/NCT02206282
org study id: IMR-LT-001
nct id: NCT02206282
lead sponsor: 
has dmc: Yes
A prospective clinical research is to assess the prevalence of implant rupture and presence
      of extracapsular gel in an un-referred population of women who have been implanted with the
      Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.
observational model: Cohort
time perspective: Prospective
measure: Magnetic Resonance Image
time frame: 1 year
description: 390 Magnetic Resonance Images.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Wanda Elizabeth Massiere Correa, MD
role: Principal Investigator
affiliation: Insituto Ivo Pitanguy
responsible party type: Sponsor
mesh term: Rupture