xml: <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/NCT06040710</url>
    </required_header>
    <id_info>
      <org_study_id>AI02</org_study_id>
      <nct_id>NCT06040710</nct_id>
    </id_info>
    <brief_title>Artificial-intelligence-based QUAntification of Size measuremeNts of Adenoma in Routine Endoscopy</brief_title>
    <acronym>AQUASNARE</acronym>
    <official_title>Artificial-intelligence-based QUAntification of Size measuremeNts of Adenoma in Routine Endoscopy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wuerzburg University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wuerzburg University 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>
        Polyp size and count determines the follow-up intervals after colonoscopy. However, relying&#xD;
        on the endoscopist's optical diagnosis for size estimation has shown considerable&#xD;
        variability, leading to erroneous surveillance intervals and increased colorectal cancer&#xD;
        risk. This study aims to assess the effectiveness of a new polyp size estimation software,&#xD;
        called POSEIDON, which uses the tip of the auxiliary water-jet as reference and is&#xD;
        implemented together with the EndoMind polyp detection system.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective:&#xD;
  &#xD;
        The primary aim of this study is to conduct a superiority analysis between POSEIDON and&#xD;
        endoscopist optical estimation, focusing on the errors of polyp size measurement. Secondary&#xD;
        objectives encompass subgroup analyses concerning varying polyp sizes and histology,&#xD;
        potential impact on follow-up protocols based on polyp sizes, and determination of the&#xD;
        percentage of cases where obtaining measurements with POSEIDON proves unfeasible.&#xD;
  &#xD;
        Study Design:&#xD;
  &#xD;
        Single center, endoscopist blinded study. Considering the results of the preliminary study, a&#xD;
        total of 42 pairs of measurements suffices to extrapolate statistical significance for a&#xD;
        power of 90% and a significance level of 0.05. Taking dropout rates, average number of polyps&#xD;
        per patient, polyp detection rate, the number of patients expected to be enrolled for the&#xD;
        study is 156. For obtaining the gold standard measurement, images from the examination&#xD;
        recording where the tip of a snare is placed next to the polyp are extracted. The snare tip&#xD;
        and polyp are manually segmented and their largest diameter in pixels is manually calculated.&#xD;
        The diameter of the snare-tip will be measured after the examination to account for&#xD;
        production based variations. Based on this, the gold standard polyp size is calculated.&#xD;
  &#xD;
        AI setup and limitations:&#xD;
  &#xD;
        The version of the polyp detection system, EndoMind, is an updated version of the one&#xD;
        published in (PMID: 35543874). Notably, the POSEIDON method has undergone dual refinements&#xD;
        from its first published version (PMID: 37080235). Firstly, the AI model for water-jet tip&#xD;
        detection has been further trained using images from colonoscopy videos, leading to&#xD;
        performance improvements. Secondly, the pixel-to-millimeter conversion methodology has been&#xD;
        optimized to align with the specifications of the endoscopes employed in the trial.&#xD;
  &#xD;
        To obtain a polyp size estimation, initially the polyp is detected by means of a bounding box&#xD;
        through the EndoMind system. Then, once water-jet is sprayed next to the polyp, POSEIDON&#xD;
        detects the tip of the water-jet, where it touches the mucosa. The coordinates of the tip in&#xD;
        the endoscopic image are correlated to the distance of the endoscope to the mucosa. With the&#xD;
        above, the largest diameter of the bounding box is converted from pixels to millimeters,&#xD;
        resulting in the size estimation.&#xD;
  &#xD;
        For measurement acquisition, the system is initiated at the beginning of the examination and&#xD;
        deactivated at its conclusion, facilitated by a dedicated button press. Concerning&#xD;
        expert-system interaction, the CADe system's identifications consistently appear on an&#xD;
        auxiliary screen within the endoscopist's workspace. On this screen, precise visualization of&#xD;
        the impact point between the water-jet beam and the mucosa follows water-jet detection.&#xD;
        Subsequently, the endoscopist receives visual affirmation of a successful calculation of&#xD;
        polyp size estimation, derived from the bounding box on the screen. The endoscopist evaluates&#xD;
        the alignment of this box around the polyp to assess the accuracy measurement outcome.&#xD;
        Importantly, throughout these operations, the endoscopist remains blinded to the size&#xD;
        estimated by POSEIDON. The endoscopist also reports polyp cases where they are unable to&#xD;
        obtain a proper measurement.&#xD;
  &#xD;
        Study population:&#xD;
  &#xD;
        All adult patients with screening or surveillance colonoscopies that do not match the&#xD;
        exclusion criteria will be asked for informed consent. Up to 3 polyps per patient will be&#xD;
        included in the final study.&#xD;
  &#xD;
        Intervention:&#xD;
  &#xD;
        Upon polyp identification by the endoscopist, the visual assessment will be conducted,&#xD;
        followed by obtaining a satisfactory measurement using POSEIDON when possible, as described&#xD;
        in the AI methods section. To eliminate potential learning bias and optimize efficiency, the&#xD;
        examiner will be blinded to the immediate measurement result. Finally, after both&#xD;
        measurements are obtained, an instrument tip of known size will be positioned adjacent to the&#xD;
        polyp, which is to be later used for obtaining the gold-standard polyp size.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Size estimation error comparison for colorectal polyps using POSEIDON versus physician optical evaluation</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>The error between gold standard polyp size and estimation using POSEIDON and optical estimation will be compared in pairs for the same polyps. If more than three polyps are measured in the same examination, 3 of them are included.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Size estimation error comparison for colorectal polyps using POSEIDON versus physician optical evaluation for different size categories</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Polyps will be split into size categories based on national and international guidelines. The study will assess the errors of both POSEIDON and optical estimation within each group through pairwise comparison</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Size estimation error comparison for colorectal polyps using POSEIDON versus physician optical evaluation for polyps with different histologies</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Polyps will be split into based on their histological evaluation. The study will assess the errors of both POSEIDON and optical estimation within each group through pairwise comparison.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Guideline-suggested follow-up interval changes based purely on detected polyp size.</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>The study determines follow-up intervals based on three international standards, solely considering polyp size estimated by the two methods.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of polyps where endoscopists failed to obtain POSEIDON measurement.</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Evaluation of the percentage polyps for which the endoscopist was unable to obtain a proper measurement with the proposed method.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">156</enrollment>
    <condition>Colorectal Polyp</condition>
    <condition>Colorectal Adenoma</condition>
    <arm_group>
      <arm_group_label>Experimental: Intervention arm</arm_group_label>
      <description>All patients within the study are included in the intervention arm: polyp detected within these patients will be measured according to the study protocol using two different methods.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>POSEIDON size estimation software with the EndoMind polyp detection system</intervention_name>
      <description>Polyp size estimation using the POSEIDON software and bounding boxes of the EndoMind polyp detection system.</description>
      <arm_group_label>Experimental: Intervention arm</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients (&gt;18 years), scheduled for screening, surveillance, or diagnostic&#xD;
          colonoscopy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients&#xD;
  &#xD;
            -  Scheduled for colonoscopy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patient Level:&#xD;
  &#xD;
            -  Inflammatory Bowel Disease&#xD;
  &#xD;
            -  Familiar Polyposis Syndrome&#xD;
  &#xD;
            -  Patient after radiation/resection of colonic parts&#xD;
  &#xD;
          Data Level&#xD;
  &#xD;
            -  Failure to initialize system before examination&#xD;
  &#xD;
            -  Missing instrument placement next to polyp to obtain gold standard&#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>Alexander Hann, Professor</last_name>
      <phone>+49 931 201-45918</phone>
      <email>hann_a@ukw.de</email>
    </overall_contact>
    <location>
      <facility>
        <name>Universitätsklinikum Würzburg</name>
        <address>
          <city>Würzburg</city>
          <state>Bayern</state>
          <zip>97080</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Polyp Size</keyword>
    <keyword>Colorectal Polyp</keyword>
    <keyword>Artificial Intelligence</keyword>
    <keyword>Endoscopy</keyword>
    <keyword>Follow-up interval</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040710
  org study id: AI02
  nct id: NCT06040710
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Polyp size and count determines the follow-up intervals after colonoscopy. However, relying
        on the endoscopist's optical diagnosis for size estimation has shown considerable
        variability, leading to erroneous surveillance intervals and increased colorectal cancer
        risk. This study aims to assess the effectiveness of a new polyp size estimation software,
        called POSEIDON, which uses the tip of the auxiliary water-jet as reference and is
        implemented together with the EndoMind polyp detection system.
  Objective:
  
        The primary aim of this study is to conduct a superiority analysis between POSEIDON and
        endoscopist optical estimation, focusing on the errors of polyp size measurement. Secondary
        objectives encompass subgroup analyses concerning varying polyp sizes and histology,
        potential impact on follow-up protocols based on polyp sizes, and determination of the
        percentage of cases where obtaining measurements with POSEIDON proves unfeasible.
  
        Study Design:
  
        Single center, endoscopist blinded study. Considering the results of the preliminary study, a
        total of 42 pairs of measurements suffices to extrapolate statistical significance for a
        power of 90% and a significance level of 0.05. Taking dropout rates, average number of polyps
        per patient, polyp detection rate, the number of patients expected to be enrolled for the
        study is 156. For obtaining the gold standard measurement, images from the examination
        recording where the tip of a snare is placed next to the polyp are extracted. The snare tip
        and polyp are manually segmented and their largest diameter in pixels is manually calculated.
        The diameter of the snare-tip will be measured after the examination to account for
        production based variations. Based on this, the gold standard polyp size is calculated.
  
        AI setup and limitations:
  
        The version of the polyp detection system, EndoMind, is an updated version of the one
        published in (PMID: 35543874). Notably, the POSEIDON method has undergone dual refinements
        from its first published version (PMID: 37080235). Firstly, the AI model for water-jet tip
        detection has been further trained using images from colonoscopy videos, leading to
        performance improvements. Secondly, the pixel-to-millimeter conversion methodology has been
        optimized to align with the specifications of the endoscopes employed in the trial.
  
        To obtain a polyp size estimation, initially the polyp is detected by means of a bounding box
        through the EndoMind system. Then, once water-jet is sprayed next to the polyp, POSEIDON
        detects the tip of the water-jet, where it touches the mucosa. The coordinates of the tip in
        the endoscopic image are correlated to the distance of the endoscope to the mucosa. With the
        above, the largest diameter of the bounding box is converted from pixels to millimeters,
        resulting in the size estimation.
  
        For measurement acquisition, the system is initiated at the beginning of the examination and
        deactivated at its conclusion, facilitated by a dedicated button press. Concerning
        expert-system interaction, the CADe system's identifications consistently appear on an
        auxiliary screen within the endoscopist's workspace. On this screen, precise visualization of
        the impact point between the water-jet beam and the mucosa follows water-jet detection.
        Subsequently, the endoscopist receives visual affirmation of a successful calculation of
        polyp size estimation, derived from the bounding box on the screen. The endoscopist evaluates
        the alignment of this box around the polyp to assess the accuracy measurement outcome.
        Importantly, throughout these operations, the endoscopist remains blinded to the size
        estimated by POSEIDON. The endoscopist also reports polyp cases where they are unable to
        obtain a proper measurement.
  
        Study population:
  
        All adult patients with screening or surveillance colonoscopies that do not match the
        exclusion criteria will be asked for informed consent. Up to 3 polyps per patient will be
        included in the final study.
  
        Intervention:
  
        Upon polyp identification by the endoscopist, the visual assessment will be conducted,
        followed by obtaining a satisfactory measurement using POSEIDON when possible, as described
        in the AI methods section. To eliminate potential learning bias and optimize efficiency, the
        examiner will be blinded to the immediate measurement result. Finally, after both
        measurements are obtained, an instrument tip of known size will be positioned adjacent to the
        polyp, which is to be later used for obtaining the gold-standard polyp size.
  observational model: Case-Only
  time perspective: Prospective
  measure: Size estimation error comparison for colorectal polyps using POSEIDON versus physician optical evaluation
  time frame: Through study completion, an average of 5 months
  description: The error between gold standard polyp size and estimation using POSEIDON and optical estimation will be compared in pairs for the same polyps. If more than three polyps are measured in the same examination, 3 of them are included.
  measure: Size estimation error comparison for colorectal polyps using POSEIDON versus physician optical evaluation for different size categories
  time frame: Through study completion, an average of 5 months
  description: Polyps will be split into size categories based on national and international guidelines. The study will assess the errors of both POSEIDON and optical estimation within each group through pairwise comparison
  measure: Size estimation error comparison for colorectal polyps using POSEIDON versus physician optical evaluation for polyps with different histologies
  time frame: Through study completion, an average of 5 months
  description: Polyps will be split into based on their histological evaluation. The study will assess the errors of both POSEIDON and optical estimation within each group through pairwise comparison.
  measure: Guideline-suggested follow-up interval changes based purely on detected polyp size.
  time frame: Through study completion, an average of 5 months
  description: The study determines follow-up intervals based on three international standards, solely considering polyp size estimated by the two methods.
  measure: Percentage of polyps where endoscopists failed to obtain POSEIDON measurement.
  time frame: Through study completion, an average of 5 months
  description: Evaluation of the percentage polyps for which the endoscopist was unable to obtain a proper measurement with the proposed method.
  arm group label: Experimental: Intervention arm
  description: All patients within the study are included in the intervention arm: polyp detected within these patients will be measured according to the study protocol using two different methods.
  intervention type: Device
  intervention name: POSEIDON size estimation software with the EndoMind polyp detection system
  description: Polyp size estimation using the POSEIDON software and bounding boxes of the EndoMind polyp detection system.
  arm group label: Experimental: Intervention arm
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alexander Hann, Professor
  phone: +49 931 201-45918
  email: hann_a@ukw.de
  facility: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Adenoma
  sharing ipd: No