<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/NCT03840590</url>
  </required_header>
  <id_info>
    <org_study_id>SINOCOLO2019B</org_study_id>
    <nct_id>NCT03840590</nct_id>
  </id_info>
  <brief_title>Adenoma Detection Rate Using AI System in China</brief_title>
  <acronym>SinoAIADR</acronym>
  <official_title>Adenoma Detection Rate Using Artificial Intelligence System in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Nankai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Changhai Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is&#xD;
&#xD;
      - to explore the usefulness of Artificial Intelligence system in colonoscopy on adenoma&#xD;
      detection rate (ADR). Other aims include to explore the data below when Artificial&#xD;
      Intelligence is used.&#xD;
&#xD;
      Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp&#xD;
      detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure,&#xD;
      MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes&#xD;
      cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and&#xD;
      remove them. Removing adenomas is known to reduce the chances of a person developing&#xD;
      colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot&#xD;
      of researches into how to improve &quot;adenoma detection rates&quot;.&#xD;
&#xD;
      A new AI system, called the CSK endoscopic diagnosis and treatment system has been designed&#xD;
      to improve the rate of polyp detection at colonoscopy. Previous tests have shown that there&#xD;
      is a significant improvement in detection of adenomas when the system is used. This study&#xD;
      will randomize patients coming for colonoscopy to have their procedure performed as usual or&#xD;
      as an AI-assisted colonoscopy. The investigators will record polyp and adenoma detection&#xD;
      rates, duration of procedure, participant comfort levels, and complications. All patients&#xD;
      referred for colonoscopy will be invited in 4 centers, recruiting a total of 800&#xD;
      participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2019</start_date>
  <completion_date type="Actual">December 5, 2019</completion_date>
  <primary_completion_date type="Actual">December 5, 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>
    <intervention_model_description>CSK endoscopic diagnosis and treatment system a new system of artificial intelligence. It is manufactured by Tianjin Yujin Limited in China. It is equipped with the endoscopic mainframe and has the access to the endoscopic video and image. When lesion-like objects appear in the real-time video, the system will alarm the examiners by sound.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma detection rate, ADR</measure>
    <time_frame>At the end of the procedure, up to 1 hour.</time_frame>
    <description>ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Polyp detection rate, PDR</measure>
    <time_frame>At the end of the procedure, up to 1 hour.</time_frame>
    <description>PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">743</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <condition>Colonic Polyp</condition>
  <condition>Adenoma</condition>
  <arm_group>
    <arm_group_label>AI-assisted Colonoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm undergo AI-assisted colonoscopy using CSK AI system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Colonoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm undergo standard colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CSK AI system</intervention_name>
    <description>CSK system is equipped with the endoscopic mainframe and alarms the examiners when suspect lesions appear.</description>
    <arm_group_label>AI-assisted Colonoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Colonoscopy</intervention_name>
    <description>This is the routine examination in nowadays clinical practice. Both the equipment and the procedure are as usual as clinical routine.</description>
    <arm_group_label>Standard Colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients referred for screening, surveillance, or diagnostic colonoscopy&#xD;
&#xD;
          -  All patients must be able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any absolute contraindications to colonoscopy&#xD;
&#xD;
          -  Patients with established or suspicion of large bowel obstruction or&#xD;
             pseudo-obstruction&#xD;
&#xD;
          -  Patients with known colon cancer or polyposis syndromes&#xD;
&#xD;
          -  Patients with known colonic strictures&#xD;
&#xD;
          -  Patients with known severe diverticular segments (that is likely to impede colonoscope&#xD;
             passage)&#xD;
&#xD;
          -  Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis,&#xD;
             infective colitis)&#xD;
&#xD;
          -  Patients lacking capacity to give informed consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who&#xD;
             have not stopped this for the procedure.&#xD;
&#xD;
          -  Patients who are attending for a therapeutic procedure or assessment of a known lesion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>En-Da YU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhai Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sixth affiliated Hospital, Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Nankai Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin People's Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300121</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>September 24, 2020</last_update_submitted>
  <last_update_submitted_qc>September 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>En-Da Yu</investigator_full_name>
    <investigator_title>Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy</investigator_title>
  </responsible_party>
  <keyword>adenoma detection rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Colonic Polyps</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03840590
org study id: SINOCOLO2019B
nct id: NCT03840590
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is

      - to explore the usefulness of Artificial Intelligence system in colonoscopy on adenoma
      detection rate (ADR). Other aims include to explore the data below when Artificial
      Intelligence is used.

      Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp
      detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure,
      MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes
      cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and
      remove them. Removing adenomas is known to reduce the chances of a person developing
      colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot
      of researches into how to improve "adenoma detection rates".

      A new AI system, called the CSK endoscopic diagnosis and treatment system has been designed
      to improve the rate of polyp detection at colonoscopy. Previous tests have shown that there
      is a significant improvement in detection of adenomas when the system is used. This study
      will randomize patients coming for colonoscopy to have their procedure performed as usual or
      as an AI-assisted colonoscopy. The investigators will record polyp and adenoma detection
      rates, duration of procedure, participant comfort levels, and complications. All patients
      referred for colonoscopy will be invited in 4 centers, recruiting a total of 800
      participants.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: CSK endoscopic diagnosis and treatment system a new system of artificial intelligence. It is manufactured by Tianjin Yujin Limited in China. It is equipped with the endoscopic mainframe and has the access to the endoscopic video and image. When lesion-like objects appear in the real-time video, the system will alarm the examiners by sound.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Adenoma detection rate, ADR
time frame: At the end of the procedure, up to 1 hour.
description: ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
measure: Polyp detection rate, PDR
time frame: At the end of the procedure, up to 1 hour.
description: PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.
arm group label: AI-assisted Colonoscopy
arm group type: Experimental
description: Participants in this arm undergo AI-assisted colonoscopy using CSK AI system.
arm group label: Standard Colonoscopy
arm group type: Active Comparator
description: Participants in this arm undergo standard colonoscopy.
intervention type: Device
intervention name: CSK AI system
description: CSK system is equipped with the endoscopic mainframe and alarms the examiners when suspect lesions appear.
arm group label: AI-assisted Colonoscopy
intervention type: Device
intervention name: Standard Colonoscopy
description: This is the routine examination in nowadays clinical practice. Both the equipment and the procedure are as usual as clinical routine.
arm group label: Standard Colonoscopy
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: En-Da YU, MD
role: Principal Investigator
affiliation: Changhai Hospital
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: En-Da Yu
investigator title: Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy
mesh term: Adenoma
mesh term: Colorectal Neoplasms
mesh term: Colonic Polyps
sharing ipd: No