<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/NCT04485715</url>
  </required_header>
  <id_info>
    <org_study_id>2020SDU-QILU-0714</org_study_id>
    <nct_id>NCT04485715</nct_id>
  </id_info>
  <brief_title>Application of AI in Polypectomy</brief_title>
  <official_title>Application of Artificial Intelligence in Colorectal Polypectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yanqing Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</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>
      The aim of this study was to assess the performance of AI system in polypectomy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 21, 2020</start_date>
  <completion_date type="Anticipated">September 21, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 21, 2021</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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>polypectomy time</measure>
    <time_frame>12 months</time_frame>
    <description>the time for detection in polypectomy</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Colonic Polyp</condition>
  <arm_group>
    <arm_group_label>AI-aided group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AI system</intervention_name>
    <description>The real-time assistance of AI system</description>
    <arm_group_label>AI-aided group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  to undergo colorectal polypectomy;&#xD;
&#xD;
          -  agree to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with the contraindications to colorectal polypectomy;&#xD;
&#xD;
          -  patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;&#xD;
&#xD;
          -  patients with high suspicion of polyposis syndromes, IBD and typical advanced CRC;&#xD;
&#xD;
          -  patients refused to participate in the trial;&#xD;
&#xD;
          -  the procedure cannot be completed due to stenosis, obstruction, huge occupying&#xD;
             lesions, or solid stool;&#xD;
&#xD;
          -  the procedure have to be terminated due to complications of anaesthesia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yanqing Li, PhD, MD</last_name>
    <phone>86-531-82166095</phone>
    <email>liyanqing@sdu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gastroenterology, Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanqing Li, PhD, MD</last_name>
      <phone>86-531-82166095</phone>
      <email>liyanqing@sdu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Yanqing Li</investigator_full_name>
    <investigator_title>gastroenterology professor of Qilu Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04485715
org study id: 2020SDU-QILU-0714
nct id: NCT04485715
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to assess the performance of AI system in polypectomy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: polypectomy time
time frame: 12 months
description: the time for detection in polypectomy
arm group label: AI-aided group
arm group type: Experimental
arm group label: control group
arm group type: No Intervention
intervention type: Other
intervention name: AI system
description: The real-time assistance of AI system
arm group label: AI-aided group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yanqing Li, PhD, MD
phone: 86-531-82166095
email: liyanqing@sdu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: gastroenterology professor of Qilu Hospital
mesh term: Colonic Polyps