<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/NCT03833492</url>
  </required_header>
  <id_info>
    <org_study_id>UEMR-1.0</org_study_id>
    <nct_id>NCT03833492</nct_id>
  </id_info>
  <brief_title>UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps</brief_title>
  <official_title>Efficacy and Safety of Underwater vs. Conventional Endoscopic Mucosal Resection for the Treatment of Diminutive Non-pedunculated Colorectal Polyps：A Multicenter Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ningbo No. 1 Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ningbo No. 1 Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is being conducted to compare the efficacy and safety of two standard&#xD;
      methods of polypectomy，Conventional Endoscopic Mucosal Resection（EMR）and Underwater&#xD;
      Endoscopic Mucosal Resection（UEMR），for small colorectal polyps.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">November 12, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>complete resection rate</measure>
    <time_frame>7 days</time_frame>
    <description>complete resection rate is defined as a complete en bloc resection of a lesion with tumor-free lateral and vertical margins.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>En bloc resection rate</measure>
    <time_frame>immediately</time_frame>
    <description>En bloc resection rate was defined as the entire lesion could be removed in 1 piece instead of piecemeal resection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse event rate</measure>
    <time_frame>14 days</time_frame>
    <description>Including bleeding and perforation , etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>24 hours</time_frame>
    <description>Time to execute the program</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Colonic Polyps</condition>
  <arm_group>
    <arm_group_label>Underwater EMR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients who are randomized to the &quot; Underwater EMR&quot; arm polypectomy with water will be performed under full water emersion without the use of submucosal injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional EMR</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patients who are randomized to the &quot; Traditional EMR&quot; arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a &quot;safety cushion&quot; for resection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Underwater EMR</intervention_name>
    <description>Polypectomy is performed under full water emersion without the use of submucosal injection.</description>
    <arm_group_label>Underwater EMR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients age between 18-75 years old with non-pedunculated colonic polyps (measuring&#xD;
        between 4 and 9mm), who willing to participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. pregnancy,&#xD;
&#xD;
          2. inflammatory bowel disease,&#xD;
&#xD;
          3. familial polyposis&#xD;
&#xD;
          4. the use of anticoagulant therapy or antiplatelet therapy&#xD;
&#xD;
          5. the absence of informed patient consent.&#xD;
&#xD;
          6. Polyps showing signs of deep submucosal invasion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Gastroenterology, Haishu No.2 Hospital, Ningbo, China</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Gastroenterology, Ninghai No.2 Hospital, Ningbo, China</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ningbo first hospital</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>December 9, 2019</last_update_submitted>
  <last_update_submitted_qc>December 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2019</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>Polyps</mesh_term>
    <mesh_term>Colonic Polyps</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/NCT03833492
org study id: UEMR-1.0
nct id: NCT03833492
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This clinical trial is being conducted to compare the efficacy and safety of two standard
      methods of polypectomy，Conventional Endoscopic Mucosal Resection（EMR）and Underwater
      Endoscopic Mucosal Resection（UEMR），for small colorectal polyps.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: complete resection rate
time frame: 7 days
description: complete resection rate is defined as a complete en bloc resection of a lesion with tumor-free lateral and vertical margins.
measure: En bloc resection rate
time frame: immediately
description: En bloc resection rate was defined as the entire lesion could be removed in 1 piece instead of piecemeal resection.
measure: Adverse event rate
time frame: 14 days
description: Including bleeding and perforation , etc.
measure: Procedure time
time frame: 24 hours
description: Time to execute the program
arm group label: Underwater EMR
arm group type: Experimental
description: The patients who are randomized to the " Underwater EMR" arm polypectomy with water will be performed under full water emersion without the use of submucosal injection.
arm group label: Traditional EMR
arm group type: No Intervention
description: The patients who are randomized to the " Traditional EMR" arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection.
intervention type: Behavioral
intervention name: Underwater EMR
description: Polypectomy is performed under full water emersion without the use of submucosal injection.
arm group label: Underwater EMR
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Polyps
mesh term: Colonic Polyps