<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/NCT01696305</url>
  </required_header>
  <id_info>
    <org_study_id>Hyalobarrier_P3</org_study_id>
    <nct_id>NCT01696305</nct_id>
  </id_info>
  <brief_title>Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy</brief_title>
  <official_title>Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Green Cross Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GC Biopharma Corp</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized, double-blind, active controlled phase 3 trial in the patients&#xD;
      with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the&#xD;
      patient with the past history of thyroid surgery).&#xD;
&#xD;
      An eligible patient will be randomized and allocated to either the test group (Hyalobarrier)&#xD;
      or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in&#xD;
      detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for&#xD;
      12weeks.&#xD;
&#xD;
      During the study, both the patients and the observer for the primary and secondary efficacy&#xD;
      evaluation will be masked.&#xD;
&#xD;
      Non-inferiority of the test device (Hyalobarrier) compared to the reference device&#xD;
      (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal&#xD;
      esophageal transit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of normal esophageal transit in marshmallow esophagography</measure>
    <time_frame>6 Weeks after intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adhesion severity using VAS</measure>
    <time_frame>Baseline and 1, 6 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swallow impairment</measure>
    <time_frame>Baseline and 1, 6 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Voice impairment</measure>
    <time_frame>Baseline and 1, 6 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>voice behavior using Voice Range Profile (VRP) assessment</measure>
    <time_frame>Baseline and 1, 6 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Injury of recurrent laryngeal nerve</measure>
    <time_frame>Baseline and 1, 6 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Sore Throat within 24hours after thyroidectomy</measure>
    <time_frame>Pre- and Post (0, 24h)-opreation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>during 12 weeks after investigational device use</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Thyroid Disease</condition>
  <arm_group>
    <arm_group_label>Hyalobarrier</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml*10ml/syringe and 5cm-cannula</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guardix-SG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Poloxamer/sodium alginate mixture 6g/syringe</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hyalobarrier</intervention_name>
    <arm_group_label>Hyalobarrier</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Guardix-SG</intervention_name>
    <arm_group_label>Guardix-SG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female between 18 and 79 years of age&#xD;
&#xD;
          -  Patients diagnosed with thyroid disease who will undergo total thyroidectomy&#xD;
&#xD;
          -  Naive patients to thyroid surgery&#xD;
&#xD;
          -  Given written informed consent&#xD;
&#xD;
          -  Childbearing potential female patients who give the consent for contraception during&#xD;
             the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding female patients&#xD;
&#xD;
          -  Abnormal coagulation panel test&#xD;
&#xD;
          -  Clinically abnormal laboratory values&#xD;
&#xD;
          -  Inappropriate general health conditions&#xD;
&#xD;
          -  Past or current medication history for hyperthyroidism&#xD;
&#xD;
          -  Medication with aspirin (or anti-platelet) before surgery&#xD;
&#xD;
          -  Current medication with anticoagulants&#xD;
&#xD;
          -  Inoperable (thyroidectomy) concurrent diseases&#xD;
&#xD;
          -  Concurrent diseases/conditions which will be unable to evaluate the primary and&#xD;
             secondary outcomes&#xD;
&#xD;
          -  Participating in other interventional clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hoon Yub Kim, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Anam Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jae-Bok Lee, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kyoung Sik Park, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Konkuk University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Konkuk University Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>February 27, 2014</last_update_submitted>
  <last_update_submitted_qc>February 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thyroid disease</keyword>
  <keyword>Hyalobarrier</keyword>
  <keyword>Thyroidectomy</keyword>
  <keyword>anti-adhesive effect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Diseases</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/NCT01696305
org study id: Hyalobarrier_P3
nct id: NCT01696305
lead sponsor: 
has dmc: No
This study is a randomized, double-blind, active controlled phase 3 trial in the patients
      with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the
      patient with the past history of thyroid surgery).

      An eligible patient will be randomized and allocated to either the test group (Hyalobarrier)
      or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in
      detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for
      12weeks.

      During the study, both the patients and the observer for the primary and secondary efficacy
      evaluation will be masked.

      Non-inferiority of the test device (Hyalobarrier) compared to the reference device
      (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal
      esophageal transit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The percentage of normal esophageal transit in marshmallow esophagography
time frame: 6 Weeks after intervention
measure: Adhesion severity using VAS
time frame: Baseline and 1, 6 and 12 weeks
measure: Swallow impairment
time frame: Baseline and 1, 6 and 12 weeks
measure: Voice impairment
time frame: Baseline and 1, 6 and 12 weeks
measure: voice behavior using Voice Range Profile (VRP) assessment
time frame: Baseline and 1, 6 and 12 weeks
measure: Injury of recurrent laryngeal nerve
time frame: Baseline and 1, 6 and 12 weeks
measure: Postoperative Sore Throat within 24hours after thyroidectomy
time frame: Pre- and Post (0, 24h)-opreation
measure: Adverse Events
time frame: during 12 weeks after investigational device use
arm group label: Hyalobarrier
arm group type: Experimental
description: ACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml*10ml/syringe and 5cm-cannula
arm group label: Guardix-SG
arm group type: Active Comparator
description: Poloxamer/sodium alginate mixture 6g/syringe
intervention type: Device
intervention name: Hyalobarrier
arm group label: Hyalobarrier
intervention type: Device
intervention name: Guardix-SG
arm group label: Guardix-SG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Hoon Yub Kim, M.D., Ph.D.
role: Principal Investigator
affiliation: Korea University Anam Hospital
last name: Jae-Bok Lee, M.D., Ph.D.
role: Principal Investigator
affiliation: Korea University Guro Hospital
last name: Kyoung Sik Park, M.D., Ph.D.
role: Principal Investigator
affiliation: Konkuk University Medical Center
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Thyroid Diseases