<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/NCT04440865</url>
  </required_header>
  <id_info>
    <org_study_id>COLO-GENIUS</org_study_id>
    <nct_id>NCT04440865</nct_id>
  </id_info>
  <brief_title>Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy (COLO-GENIUS)</brief_title>
  <acronym>COLO-GENIUS</acronym>
  <official_title>Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Paris-Bercy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique Paris-Bercy</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>
      This controlled-randomized trial compares the artificial intelligence Genius® system assisted&#xD;
      (Genius+) to standard (Genius-) colonoscopy.&#xD;
&#xD;
      The aim of this study was to evaluate the impact of Genius® system on ADR in routine&#xD;
      colonoscopy. The secondary aims will be the impact of Genius® system on polyp detection rate&#xD;
      (PDR), serrated polyp detection rate (SPDR), advanced neoplasia detection rate (ANDR), mean&#xD;
      number of polyps (MNP), polyp type and localization, and operator type (according to basal&#xD;
      ADR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Any patient seen by gastroenterologists working in the endoscopy unit and meeting the&#xD;
      inclusion criteria may be recruited.&#xD;
&#xD;
      The patient will be offered to participate in the study. The information form as well as the&#xD;
      consent, will be given to the patient for a good understanding of the study and the&#xD;
      investigator in charge of the patient gives all the additional explanations necessary for&#xD;
      this good understanding (but of the study, the course, risks and benefits).&#xD;
&#xD;
      A period of reflection will be left to the patient or his family to make a free decision&#xD;
      whether or not to participate in the study.&#xD;
&#xD;
      After the consent to participate will be signed by the gastroenterologist and the patient,&#xD;
      the patient will be randomized. The use of the Genius® system will depend on the&#xD;
      randomization that will be performed at the start of the colonoscopy.&#xD;
&#xD;
      This randomization will be done in the computer examination room using the randomization&#xD;
      software.&#xD;
&#xD;
      The patient will therefore be randomized into 2 groups:&#xD;
&#xD;
      Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system&#xD;
&#xD;
      A comparison of the two groups standard colonoscopy vs colonoscopy assisted by Genius® system&#xD;
      will be made as following:&#xD;
&#xD;
      A-Main criterion:&#xD;
&#xD;
      - Adenoma detection rate (ADR)&#xD;
&#xD;
      B-Secondary criteria:&#xD;
&#xD;
      Polyps detection rate (PDR) Proximal serrated polyps detection rate (PSPDR) Neoplasia&#xD;
      detection rate (NDR) Mean number of polyps (MNP) Mean number of adenomas (MNA) Factors&#xD;
      associated with ADR&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Actual">April 20, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</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>Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system</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>1 day</time_frame>
    <description>percentage of colonoscopy with one or more adenoma of the colon</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Advanced Neoplasia Detection Rate (ANDR)</measure>
    <time_frame>1 day</time_frame>
    <description>percentage of colonoscopy with one or more advanced neoplasia of the colon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proximal Serrated Polyp Detection Rate (PSPDR)</measure>
    <time_frame>1 day</time_frame>
    <description>percentage of colonoscopy with one or more serrated polyp of the colon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Polyp Detection Rate (PDR)</measure>
    <time_frame>1 day</time_frame>
    <description>percentage of colonoscopy with one or more polyp of the colon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The factors influencing the Adenoma Detection Rate (ADR)</measure>
    <time_frame>1 day</time_frame>
    <description>Withdrawal time (in seconds): time of exploration from the caecum to the anal verge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The factors influencing the Adenoma Detection Rate (ADR)</measure>
    <time_frame>1 day</time_frame>
    <description>Boston scale (0 to 9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach caecum (sec)</measure>
    <time_frame>1 day</time_frame>
    <description>Time to reach caecum from the beginning of the procedure (in seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caecal intubation rate (%)</measure>
    <time_frame>1 day</time_frame>
    <description>Caecal intubation rate (complete colonoscopy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity: perforation rate (%)</measure>
    <time_frame>7 days after procedure</time_frame>
    <description>Perforation rates (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity: bleeding rate (%)</measure>
    <time_frame>7 days after procedure</time_frame>
    <description>Bleeding rates (%)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2100</enrollment>
  <condition>Colonic Polyp</condition>
  <condition>Colonoscopy</condition>
  <condition>Artificial Intelligence</condition>
  <condition>Colonic Adenoma</condition>
  <condition>Colonic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Arm 1- Standard colonoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard colonoscopy is performed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2- Colonoscopy assisted by Genius</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Colonoscopy assisted by Genius artificial intelligence system is performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genius® System-assisted Colonoscopy</intervention_name>
    <description>Genius® Intelligence System is used to assist Colonoscopy</description>
    <arm_group_label>Arm 2- Colonoscopy assisted by Genius</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Colonoscopy</intervention_name>
    <description>Standard Colonoscopy without Genius® Intelligence System is performed</description>
    <arm_group_label>Arm 1- Standard colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient scheduled for total colonoscopic exploration, during the period study&#xD;
&#xD;
          -  Patient over or equal to 18 years&#xD;
&#xD;
          -  ASA 1, ASA 2, ASA 3&#xD;
&#xD;
          -  No participation in another clinical study&#xD;
&#xD;
          -  Certificate of non opposition signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under 18 years old&#xD;
&#xD;
          -  ASA 4, ASA 5&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Patient with coagulation abnormalities preventing polypectomy: prothrombin level &lt;50%,&#xD;
             Platelets &lt;50000 / mm3, effective anti-coagulation in progress, clopidogrel in&#xD;
             progress.&#xD;
&#xD;
          -  Patient referred for resection of a known polyp&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  Known colonic stenosis&#xD;
&#xD;
          -  Diverticulitis less than 6 weeks old&#xD;
&#xD;
          -  Patient unable to give consent or protected by law&#xD;
&#xD;
          -  Opposition expressed for inclusion in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Karsenti, MD</last_name>
    <role>Study Director</role>
    <affiliation>Clinique Paris-Bercy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Paris-Bercy</name>
      <address>
        <city>Charenton-le-Pont</city>
        <zip>94220</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>April 30, 2022</last_update_submitted>
  <last_update_submitted_qc>April 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 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>Adenoma</mesh_term>
    <mesh_term>Colonic Neoplasms</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/NCT04440865
org study id: COLO-GENIUS
nct id: NCT04440865
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This controlled-randomized trial compares the artificial intelligence Genius® system assisted
      (Genius+) to standard (Genius-) colonoscopy.

      The aim of this study was to evaluate the impact of Genius® system on ADR in routine
      colonoscopy. The secondary aims will be the impact of Genius® system on polyp detection rate
      (PDR), serrated polyp detection rate (SPDR), advanced neoplasia detection rate (ANDR), mean
      number of polyps (MNP), polyp type and localization, and operator type (according to basal
      ADR).
Any patient seen by gastroenterologists working in the endoscopy unit and meeting the
      inclusion criteria may be recruited.

      The patient will be offered to participate in the study. The information form as well as the
      consent, will be given to the patient for a good understanding of the study and the
      investigator in charge of the patient gives all the additional explanations necessary for
      this good understanding (but of the study, the course, risks and benefits).

      A period of reflection will be left to the patient or his family to make a free decision
      whether or not to participate in the study.

      After the consent to participate will be signed by the gastroenterologist and the patient,
      the patient will be randomized. The use of the Genius® system will depend on the
      randomization that will be performed at the start of the colonoscopy.

      This randomization will be done in the computer examination room using the randomization
      software.

      The patient will therefore be randomized into 2 groups:

      Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system

      A comparison of the two groups standard colonoscopy vs colonoscopy assisted by Genius® system
      will be made as following:

      A-Main criterion:

      - Adenoma detection rate (ADR)

      B-Secondary criteria:

      Polyps detection rate (PDR) Proximal serrated polyps detection rate (PSPDR) Neoplasia
      detection rate (NDR) Mean number of polyps (MNP) Mean number of adenomas (MNA) Factors
      associated with ADR
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Arm 1- Standard colonoscopy Arm 2- Colonoscopy assisted by Genius® system
primary purpose: Diagnostic
masking: None (Open Label)
measure: Adenoma Detection Rate (ADR)
time frame: 1 day
description: percentage of colonoscopy with one or more adenoma of the colon
measure: Advanced Neoplasia Detection Rate (ANDR)
time frame: 1 day
description: percentage of colonoscopy with one or more advanced neoplasia of the colon
measure: Proximal Serrated Polyp Detection Rate (PSPDR)
time frame: 1 day
description: percentage of colonoscopy with one or more serrated polyp of the colon
measure: Polyp Detection Rate (PDR)
time frame: 1 day
description: percentage of colonoscopy with one or more polyp of the colon
measure: The factors influencing the Adenoma Detection Rate (ADR)
time frame: 1 day
description: Withdrawal time (in seconds): time of exploration from the caecum to the anal verge
measure: The factors influencing the Adenoma Detection Rate (ADR)
time frame: 1 day
description: Boston scale (0 to 9)
measure: Time to reach caecum (sec)
time frame: 1 day
description: Time to reach caecum from the beginning of the procedure (in seconds)
measure: Caecal intubation rate (%)
time frame: 1 day
description: Caecal intubation rate (complete colonoscopy)
measure: Morbidity: perforation rate (%)
time frame: 7 days after procedure
description: Perforation rates (%)
measure: Morbidity: bleeding rate (%)
time frame: 7 days after procedure
description: Bleeding rates (%)
arm group label: Arm 1- Standard colonoscopy
arm group type: Active Comparator
description: Standard colonoscopy is performed
arm group label: Arm 2- Colonoscopy assisted by Genius
arm group type: Active Comparator
description: Colonoscopy assisted by Genius artificial intelligence system is performed
intervention type: Other
intervention name: Genius® System-assisted Colonoscopy
description: Genius® Intelligence System is used to assist Colonoscopy
arm group label: Arm 2- Colonoscopy assisted by Genius
intervention type: Other
intervention name: Standard Colonoscopy
description: Standard Colonoscopy without Genius® Intelligence System is performed
arm group label: Arm 1- Standard colonoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Karsenti, MD
role: Study Director
affiliation: Clinique Paris-Bercy
facility: 
country: France
responsible party type: Sponsor
mesh term: Adenoma
mesh term: Colonic Neoplasms
mesh term: Colonic Polyps