<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/NCT03007654</url>
  </required_header>
  <id_info>
    <org_study_id>CG-AHS008</org_study_id>
    <nct_id>NCT03007654</nct_id>
  </id_info>
  <brief_title>Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)</brief_title>
  <acronym>antiadhesion</acronym>
  <official_title>Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) for Intraperitoneal Adhesion in Patient With Gynecological Surgery, a Multicenter Single-blinded, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yong Sang Song</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an&#xD;
      antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>adhesion rate</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>4 weeks after surgery, finding adhesion using visceral slide test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adhesion symptoms</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>4 weeks after surgery, Identifying adhesion sysmptoms using Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse event</measure>
    <time_frame>4 weeks after surgery</time_frame>
    <description>identifying adverse events after surgery</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">192</enrollment>
  <condition>Gynecologic Disease</condition>
  <arm_group>
    <arm_group_label>Mediclore</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>standard treatment for surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adept</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>adhesion barrier, Adept, to apply medical device fully around surgery area</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mediclore</intervention_name>
    <description>apply medical device fully around intrauterine surgery area</description>
    <arm_group_label>Mediclore</arm_group_label>
    <other_name>Poloxamer, Gelatin and Chitosan.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adept</intervention_name>
    <description>apply medical device fully around intrauterine surgery area</description>
    <arm_group_label>Adept</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Gynecological disease (benign disease)&#xD;
&#xD;
          -  Patients who Written informed consent&#xD;
&#xD;
          -  Patients without clinically significant lab&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having enrolled another clinical trials within 1 month&#xD;
&#xD;
          -  Immunosuppression or autoimmune disease&#xD;
&#xD;
          -  Anticoagulant, general steroids within a week from surgery&#xD;
&#xD;
          -  Serious diseases (heart failure, renal failure, liver failure, uncontrolled&#xD;
             hypertension, diabetes mellitus, coagulation deficiencies)&#xD;
&#xD;
          -  Patients with previous history of surgery at the same operate site&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yongsang Song, MD</last_name>
    <phone>+82-10-9580-1023</phone>
    <email>yssong@snu.ac.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria Lee, MD</last_name>
    <phone>+82-10-2991-9692</phone>
    <email>marialee@snu.ac.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoutl National University Hospital</name>
      <address>
        <city>Seoul City</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yong sang Song, MD</last_name>
      <phone>+82-10-9580-1023</phone>
    </contact>
    <contact_backup>
      <last_name>Maria Lee, MD</last_name>
      <phone>+82-10-2991-9692</phone>
      <email>marialee@snu.ac.kr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Yong Sang Song</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genital Diseases, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chitosan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03007654
org study id: CG-AHS008
nct id: NCT03007654
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an
      antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: adhesion rate
time frame: 4 weeks after surgery
description: 4 weeks after surgery, finding adhesion using visceral slide test
measure: Incidence of adhesion symptoms
time frame: 4 weeks after surgery
description: 4 weeks after surgery, Identifying adhesion sysmptoms using Questionnaire
measure: adverse event
time frame: 4 weeks after surgery
description: identifying adverse events after surgery
arm group label: Mediclore
arm group type: Experimental
description: adhesion barrier Mediclore 5cc, to apply medical device fully around surgery area
arm group label: No treatment
arm group type: No Intervention
description: standard treatment for surgery
arm group label: Adept
arm group type: Active Comparator
description: adhesion barrier, Adept, to apply medical device fully around surgery area
intervention type: Device
intervention name: Mediclore
description: apply medical device fully around intrauterine surgery area
arm group label: Mediclore
other name: Poloxamer, Gelatin and Chitosan.
intervention type: Device
intervention name: Adept
description: apply medical device fully around intrauterine surgery area
arm group label: Adept
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yongsang Song, MD
phone: +82-10-9580-1023
email: yssong@snu.ac.kr
last name: Maria Lee, MD
phone: +82-10-2991-9692
email: marialee@snu.ac.kr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Yong Sang Song
investigator title: MD
mesh term: Genital Diseases, Female
mesh term: Chitosan
sharing ipd: Undecided