<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/NCT01711710</url>
  </required_header>
  <id_info>
    <org_study_id>06-2010-095</org_study_id>
    <secondary_id>E-1005-049-001</secondary_id>
    <nct_id>NCT01711710</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant</brief_title>
  <official_title>Clinical Trial to Evaluate the Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) in Women Aged 22 and Over With Breast Reconstruction or Augmentation Mammoplasty.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HansBiomed Co.,Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled&#xD;
      Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or&#xD;
      augmentation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 30, 2010</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">October 30, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>a rate of rupture of 1%</measure>
    <time_frame>2 years</time_frame>
    <description>All the subjects have been monitored for 2 years and will be checked MRI to define rupture at 6month, 1 year and 2year after the breast implant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>a rate of capsular contracture of 5%</measure>
    <time_frame>2 years</time_frame>
    <description>The Baker classification that divided into 4 stages will be used as a reference to evaluate the capsular contracture. Only stage 3 and 4 will be confirmed as capsular contracture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>a rate of connective tissue disease</measure>
    <time_frame>2 years</time_frame>
    <description>Connective tissue disease include hair loss, erythema, photosensitivity, dry eye syndrome,myalgia,neuralgia,arthralgia, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in bust girth and actual measured bra-cup size</measure>
    <time_frame>2 years</time_frame>
    <description>Bra cup size can be determined by measuring right or left bust circumference over the nipple.&#xD;
6 inch= doubleA, 7inch=A, 8inch= B, 9inch=C, 10inch=D, 11inch=E Bust girth means bust circumference line . It can be determined by measuring around the women's torso over the fullest part of the breasts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in life satisfaction</measure>
    <time_frame>2 years</time_frame>
    <description>The subject questionaire including Rosenberg Self Esteem Scale,Body Esteem Scale,Survey of Functional-36 Status Survey will be assessed at 6month, 1year and 2year after the intervention</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Cohesive Gel Breast Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohesive Silicone Gel-Filled Breast Implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cohesive Gel Breast Implant</intervention_name>
    <description>Cohesive Silicone Gel-Filled Breast Implant insert under the submuscular with axillary incision in breast augmentation mammoplasty.&#xD;
Remove tissue expander and insert Cohesive Silicone Gel-Filled Breast Implant in breast reconstruction.</description>
    <arm_group_label>Cohesive Gel Breast Implant</arm_group_label>
    <other_name>Cohesive Silicone Gel-Filled Breast Implant(CoSBI)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 22 years of age&#xD;
&#xD;
          -  Subjects who want breast augmentation reconstruction following breast cancer,&#xD;
             congenital or accidental unbalanced breast size&#xD;
&#xD;
          -  Negative pregnancy test in fertile women&#xD;
&#xD;
          -  Subjects who voluntarily decided the participation of the study and signed the&#xD;
             informed consent&#xD;
&#xD;
          -  Subjects who can understand and comply with the instructions and participate during&#xD;
             the entire period of the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous breast reconstruction or augmentation history&#xD;
&#xD;
          -  self -immune disease&#xD;
&#xD;
          -  uncontrolled active infectious disease&#xD;
&#xD;
          -  unable to insert beast implant due to radiotherapy&#xD;
&#xD;
          -  Patients who have recurrent breast cancer or do not treat effectively their cancer&#xD;
&#xD;
          -  Keloid&#xD;
&#xD;
          -  Abnormal blood test or ECG result for general anesthesia&#xD;
&#xD;
          -  Patients who cannot MRI scan due to having Metallic substance in the body or&#xD;
             Claustrophobia&#xD;
&#xD;
          -  Aesthetic addiction, drug abuse, alcohol abuse&#xD;
&#xD;
          -  Patients who are not eligible for this study at the medical discretion of the&#xD;
             Principal Investigator or Sub-investigator&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chanyeong Heo, Ph. D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>reconstruction</keyword>
  <keyword>augmentation</keyword>
  <keyword>cohesive silicone gel</keyword>
  <keyword>breast implant</keyword>
  <keyword>rupture</keyword>
  <keyword>capsular contracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT01711710
org study id: 06-2010-095
secondary id: E-1005-049-001
nct id: NCT01711710
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled
      Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or
      augmentation
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: a rate of rupture of 1%
time frame: 2 years
description: All the subjects have been monitored for 2 years and will be checked MRI to define rupture at 6month, 1 year and 2year after the breast implant.
measure: a rate of capsular contracture of 5%
time frame: 2 years
description: The Baker classification that divided into 4 stages will be used as a reference to evaluate the capsular contracture. Only stage 3 and 4 will be confirmed as capsular contracture.
measure: a rate of connective tissue disease
time frame: 2 years
description: Connective tissue disease include hair loss, erythema, photosensitivity, dry eye syndrome,myalgia,neuralgia,arthralgia, etc.
measure: Changes in bust girth and actual measured bra-cup size
time frame: 2 years
description: Bra cup size can be determined by measuring right or left bust circumference over the nipple.
6 inch= doubleA, 7inch=A, 8inch= B, 9inch=C, 10inch=D, 11inch=E Bust girth means bust circumference line . It can be determined by measuring around the women's torso over the fullest part of the breasts.
measure: Change in life satisfaction
time frame: 2 years
description: The subject questionaire including Rosenberg Self Esteem Scale,Body Esteem Scale,Survey of Functional-36 Status Survey will be assessed at 6month, 1year and 2year after the intervention
arm group label: Cohesive Gel Breast Implant
arm group type: Experimental
description: Cohesive Silicone Gel-Filled Breast Implant
intervention type: Device
intervention name: Cohesive Gel Breast Implant
description: Cohesive Silicone Gel-Filled Breast Implant insert under the submuscular with axillary incision in breast augmentation mammoplasty.
Remove tissue expander and insert Cohesive Silicone Gel-Filled Breast Implant in breast reconstruction.
arm group label: Cohesive Gel Breast Implant
other name: Cohesive Silicone Gel-Filled Breast Implant(CoSBI)
criteria: 
gender: Female
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chanyeong Heo, Ph. D
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Breast Neoplasms