<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/NCT04453956</url>
  </required_header>
  <id_info>
    <org_study_id>EA-19-001</org_study_id>
    <nct_id>NCT04453956</nct_id>
  </id_info>
  <brief_title>A Single Center Study on Comparing the Different Function of EndoAngel in Improving the Quality of Colonscopy</brief_title>
  <official_title>A Prospective, Randomized, Single-blind, 2 × 2 Factorial Design Single Center Study Evaluating the Polyp Detection and Quality Monitoring Function of EndoAngel in Improving the Quality of Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Renmin Hospital of Wuhan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Renmin Hospital of Wuhan University</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>
      An artificial intelligence-based system, named EndoAngel,has been constructed&#xD;
      previously,which has polyp detection and quality monitoring functions. This study aims to&#xD;
      evaluate the two different functions of EndoAngle in improving adenoma detection rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The detection and removal of precancerous polyps via colonoscopy can reduce the the risk of&#xD;
      colon cancer. However, the detection rate of adenomatous polyps can vary significantly among&#xD;
      endoscopists. EndoAngel is an artificial intelligence-based system,consisting of polyp&#xD;
      detection and quality monitoring functions. The polyp detection function can remind&#xD;
      endoscopists of the location of the polyp. The quality monitoring function can monitor the&#xD;
      velocity of insertion of the endoscope, record the time of insertion and withdrawal of the&#xD;
      endoscope, and remind endoscopists of the blind areas caused by intestinal segment&#xD;
      slipping.This study aims to evaluate the two different functions of EndoAngle by 2 × 2&#xD;
      factorial design in improving adenoma detection rate and the quality of colonscopy .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 20, 2020</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>Factorial Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>3 Months</time_frame>
    <description>The numerator is the number of cases of adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Polyp detection rate</measure>
    <time_frame>3 months</time_frame>
    <description>The numerator is the number of cases of polyps detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean number of polyps per procedure</measure>
    <time_frame>3 months</time_frame>
    <description>The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean number of adenomas per procedure</measure>
    <time_frame>3 months</time_frame>
    <description>The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection rate of large, small and diminutive polyps</measure>
    <time_frame>3 months</time_frame>
    <description>The numerator was the number of patients with large (≥10 mm), small (&gt;5 to &lt;10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean number of large, small and diminutive polyps per procedure</measure>
    <time_frame>3 months</time_frame>
    <description>The numerator was the number of large (≥10 mm), small (&gt;5 to &lt;10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection rate of large, small and diminutive adenomas</measure>
    <time_frame>3 months</time_frame>
    <description>The numerator was the number of patients with large (≥10 mm), small (&gt;5 to &lt;10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean number of large, small and diminutive adenomas per procedure</measure>
    <time_frame>3 months</time_frame>
    <description>The numerator was the number of large (≥10 mm), small (&gt;5 to &lt;10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection rate of adenoma in different sites</measure>
    <time_frame>3 months</time_frame>
    <description>The numerator is the number of cases of adenoma detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean number of adenomas in different sites per procedure</measure>
    <time_frame>3 months</time_frame>
    <description>The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of colonoscopic insertion</measure>
    <time_frame>3 months</time_frame>
    <description>The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of colonoscopic withdrawal</measure>
    <time_frame>3 months</time_frame>
    <description>The duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cecal intubation rate</measure>
    <time_frame>3 months</time_frame>
    <description>The numerator is the number of cases of colonoscopy reaching ileocecal valve or appendiceal opening, and the denominator is the total number of colonoscopy cases.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">1090</enrollment>
  <condition>Adenoma</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will receive colonoscopy without assistance of EndoAngel's any function.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Polyp detection function group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection function.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quality monitoring function group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Polyp detection plus quality monitoring functions group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Colonoscopy with the assistance of EndoAngel's polyp detection function.</intervention_name>
    <description>Patient in this group will receive colonoscopy with assistance of EndoAngel's polyp detection function,which can remind endoscopists of the location of the polyp.</description>
    <arm_group_label>Polyp detection function group</arm_group_label>
    <arm_group_label>Polyp detection plus quality monitoring functions group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Colonoscopy with the assistance of EndoAngel's quality monitoring function.</intervention_name>
    <description>Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.</description>
    <arm_group_label>Polyp detection plus quality monitoring functions group</arm_group_label>
    <arm_group_label>Quality monitoring function group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Colonoscopy without the assistance of EndoAngel's any function.</intervention_name>
    <description>Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female aged 18 years or above;&#xD;
&#xD;
          2. Colonoscopy is needed to further characterize gastrointestinal diseases;&#xD;
&#xD;
          3. Ability to read, understand and sign informed consent forms;&#xD;
&#xD;
          4. The researchers believe that the subjects can understand the process of the clinical&#xD;
             study and are willing and able to complete all the study procedures and follow-up&#xD;
             visits to cooperate with the study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participated in other clinical trials, signed informed consent forms and followed up&#xD;
             in other clinical trials；&#xD;
&#xD;
          2. Participate in a drug clinical trial and during the elution period of the trial or&#xD;
             control drug；&#xD;
&#xD;
          3. Drug or alcohol abuse or mental disorder in the last 5 years;&#xD;
&#xD;
          4. Pregnant or lactating women;&#xD;
&#xD;
          5. Patients with multiple polyp syndrome;&#xD;
&#xD;
          6. Patients with a history of inflammatory bowel disease, colorectal cancer, or&#xD;
             colorectal surgery;&#xD;
&#xD;
          7. Patients with known perforation or colonic obstruction;&#xD;
&#xD;
          8. Patients with a contraindication for biopsy;&#xD;
&#xD;
          9. The researchers did not consider the subjects suitable for colonoscopy;&#xD;
&#xD;
         10. The researchers determined that the subjects had high-risk diseases or other special&#xD;
             conditions that were not appropriate for clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Honggang Yu, MD</last_name>
    <phone>+8613871281899</phone>
    <email>yuhonggang1968@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Renmin Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Honggang Yu, MD</last_name>
      <phone>+8613871281899</phone>
      <email>yuhonggang1968@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Polyp Detection</keyword>
  <keyword>Quality Monitoring</keyword>
  <keyword>Artificial Intelligence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>April 11, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04453956
org study id: EA-19-001
nct id: NCT04453956
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An artificial intelligence-based system, named EndoAngel,has been constructed
      previously,which has polyp detection and quality monitoring functions. This study aims to
      evaluate the two different functions of EndoAngle in improving adenoma detection rate.
The detection and removal of precancerous polyps via colonoscopy can reduce the the risk of
      colon cancer. However, the detection rate of adenomatous polyps can vary significantly among
      endoscopists. EndoAngel is an artificial intelligence-based system,consisting of polyp
      detection and quality monitoring functions. The polyp detection function can remind
      endoscopists of the location of the polyp. The quality monitoring function can monitor the
      velocity of insertion of the endoscope, record the time of insertion and withdrawal of the
      endoscope, and remind endoscopists of the blind areas caused by intestinal segment
      slipping.This study aims to evaluate the two different functions of EndoAngle by 2 × 2
      factorial design in improving adenoma detection rate and the quality of colonscopy .
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Adenoma detection rate
time frame: 3 Months
description: The numerator is the number of cases of adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
measure: Polyp detection rate
time frame: 3 months
description: The numerator is the number of cases of polyps detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
measure: The mean number of polyps per procedure
time frame: 3 months
description: The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
measure: The mean number of adenomas per procedure
time frame: 3 months
description: The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
measure: Detection rate of large, small and diminutive polyps
time frame: 3 months
description: The numerator was the number of patients with large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
measure: The mean number of large, small and diminutive polyps per procedure
time frame: 3 months
description: The numerator was the number of large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
measure: Detection rate of large, small and diminutive adenomas
time frame: 3 months
description: The numerator was the number of patients with large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
measure: The mean number of large, small and diminutive adenomas per procedure
time frame: 3 months
description: The numerator was the number of large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
measure: Detection rate of adenoma in different sites
time frame: 3 months
description: The numerator is the number of cases of adenoma detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
measure: The mean number of adenomas in different sites per procedure
time frame: 3 months
description: The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
measure: Time of colonoscopic insertion
time frame: 3 months
description: The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening
measure: Time of colonoscopic withdrawal
time frame: 3 months
description: The duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished.
measure: Cecal intubation rate
time frame: 3 months
description: The numerator is the number of cases of colonoscopy reaching ileocecal valve or appendiceal opening, and the denominator is the total number of colonoscopy cases.
arm group label: Control group
arm group type: Sham Comparator
description: Patients will receive colonoscopy without assistance of EndoAngel's any function.
arm group label: Polyp detection function group
arm group type: Experimental
description: Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection function.
arm group label: Quality monitoring function group
arm group type: Experimental
description: Patients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function.
arm group label: Polyp detection plus quality monitoring functions group
arm group type: Experimental
description: Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.
intervention type: Diagnostic Test
intervention name: Colonoscopy with the assistance of EndoAngel's polyp detection function.
description: Patient in this group will receive colonoscopy with assistance of EndoAngel's polyp detection function,which can remind endoscopists of the location of the polyp.
arm group label: Polyp detection function group
arm group label: Polyp detection plus quality monitoring functions group
intervention type: Diagnostic Test
intervention name: Colonoscopy with the assistance of EndoAngel's quality monitoring function.
description: Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.
arm group label: Polyp detection plus quality monitoring functions group
arm group label: Quality monitoring function group
intervention type: Diagnostic Test
intervention name: Colonoscopy without the assistance of EndoAngel's any function.
description: Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Honggang Yu, MD
phone: +8613871281899
email: yuhonggang1968@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Adenoma
submitted: April 11, 2023