<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/NCT02978391</url>
  </required_header>
  <id_info>
    <org_study_id>NEXTBIO-631-EWD3</org_study_id>
    <nct_id>NCT02978391</nct_id>
  </id_info>
  <brief_title>UI-EWD for Endoscopic Hemostasis of Bleeding Peptic Ulcers and Bleeding After EMR/ESD</brief_title>
  <official_title>A Prospective, Multicenter, Single-blind, Controlled Clinical Trial to Confirm the Efficacy and Safety of 'UI-EWD', a Wound Dressing Used for Wound Protection and Hemostasis After Ulcer Bleeding Due to Peptic Ulcer, EMR and ESD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Next Biomedical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Next Biomedical Co., Ltd.</source>
  <brief_summary>
    <textblock>
      UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic&#xD;
      treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      UI-EWD (Endoscopic Wound Dressing) is adhesive absorbable powder as a new hemostasis&#xD;
      material, the therapeutic effect and safety in endoscopic application will be verified. This&#xD;
      study has been designed to observe comparing UI-EWD versus the submucosal epinephrine&#xD;
      injection for endoscopic hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2016</start_date>
  <completion_date type="Actual">September 18, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrent bleeding rate</measure>
    <time_frame>3 days</time_frame>
    <description>Rebleeding rate up to 3 days was obtained by clinical manifestations such as melana; decreased hemoglobin &gt; 2g/dL; hemodynamic instability or active bleeding from mucosal defect under endoscope.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Upper Gastrointestinal Bleeding</condition>
  <arm_group>
    <arm_group_label>UI-EWD Hemostatic system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with upper gastrointestinal bleeding treated with UI-EWD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>epinephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UI-EWD Hemostatic system</intervention_name>
    <description>Adhesive endoscopic hemostats, powder type</description>
    <arm_group_label>UI-EWD Hemostatic system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>epinephrine endoscopic injection (conventional therapy)</intervention_name>
    <description>endoscopic submucosal injection of epinephrine (1: 10,000)</description>
    <arm_group_label>epinephrine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of bleeding peptic ulcer and active bleeding after ESD/EMR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulation disorder (PLT &lt; 50*10^9/L, INR &gt; 2)&#xD;
&#xD;
          -  Connot stop taking the antiplatelet drug, NSAID, Anticoagulant drug, and Aspirin&#xD;
             during endoscopic treatment and after 72h endoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yong-Woon Shin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inha University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Soonchunhyang University College of Medicine</name>
      <address>
        <city>Bucheon</city>
        <zip>14584</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <zip>22332</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>March 31, 2022</last_update_submitted>
  <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2022</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>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Peptic Ulcer</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Hemostatics</mesh_term>
  </intervention_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/NCT02978391
org study id: NEXTBIO-631-EWD3
nct id: NCT02978391
lead sponsor: 
UI-EWD (NextBiomedical Co, Incheon, South Korea), a new hemostatic powder for endoscopic
      treatment of high-risk bleeding peptic ulcers and bleeding after ESD/EMR.
UI-EWD (Endoscopic Wound Dressing) is adhesive absorbable powder as a new hemostasis
      material, the therapeutic effect and safety in endoscopic application will be verified. This
      study has been designed to observe comparing UI-EWD versus the submucosal epinephrine
      injection for endoscopic hemostasis of bleeding peptic ulcers and bleeding after EMR/ESD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Recurrent bleeding rate
time frame: 3 days
description: Rebleeding rate up to 3 days was obtained by clinical manifestations such as melana; decreased hemoglobin > 2g/dL; hemodynamic instability or active bleeding from mucosal defect under endoscope.
arm group label: UI-EWD Hemostatic system
arm group type: Experimental
description: Patients with upper gastrointestinal bleeding treated with UI-EWD
arm group label: epinephrine
arm group type: Active Comparator
description: Patients with upper gastrointestinal bleeding treated with submucosal epinephrine injection
intervention type: Device
intervention name: UI-EWD Hemostatic system
description: Adhesive endoscopic hemostats, powder type
arm group label: UI-EWD Hemostatic system
intervention type: Drug
intervention name: epinephrine endoscopic injection (conventional therapy)
description: endoscopic submucosal injection of epinephrine (1: 10,000)
arm group label: epinephrine
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yong-Woon Shin
role: Principal Investigator
affiliation: Inha University Hospital
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Gastrointestinal Hemorrhage
mesh term: Peptic Ulcer
mesh term: Hemorrhage
mesh term: Epinephrine
mesh term: Hemostatics