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/NCT05973227</url>
    </required_header>
    <id_info>
      <org_study_id>1094572-01C</org_study_id>
      <nct_id>NCT05973227</nct_id>
    </id_info>
    <brief_title>InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections</brief_title>
    <acronym>TRIDENT</acronym>
    <official_title>InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections: Observational First-in-human Pilot Safety Trial -TRIDENT-</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Intuitive Surgical</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Intuitive Surgical</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 objective of the study is to assess the safety and technical feasibility of a new imaging&#xD;
        system, used during colorectal resection surgery, named Trident in version 1.0, which could&#xD;
        be used by the surgeon during colorectal procedures to obtain information on intestinal&#xD;
        tissue oxygenation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, non-randomized, single center, feasibility trial. All consecutive&#xD;
        patients that fulfil the inclusion/exclusion criteria will be informed about the possibility&#xD;
        to be included in the present clinical investigation. Only subjects that have signed the&#xD;
        study informed consent will be included in the study. The Trident System v1.0 will be used&#xD;
        only during approximately 2 to 5 minutes during a precise surgical step, i.e., just before&#xD;
        the final resection of the surgical specimen. Patients will be prospectively followed at 30&#xD;
        days post-surgery. Data will be collected prospectively from the medical records.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 6, 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery.</measure>
      <time_frame>30 days FU</time_frame>
      <description>descriptive analysis on the quality images by the engineering design team and feedback provided by clinical experts (surgeons) according to ad hoc form evaluating: 1) ergonomics aspects; 2) workflow; 3) risks of breaching sterility; 4) Speed of image acquisition.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>- level of oxygenation (StO2) of the exteriorized colon before resection with the Trident System v1.0 - the level of oxygenation (StO2) provided by the system at the site chosen by the surgeon based on the clinical evaluation.</measure>
      <time_frame>surgery day</time_frame>
      <description>Measurement of StO2 values at the resection site determined by the surgeon based on his clinical judgment and measurement of StO2 levels over the entire length of the colon exteriorized and visible in the field of view of the Trident System v1.0.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Left-sided Colorectal Resection : Diverticular Diseases</condition>
    <condition>Left-sided Colorectal Resection : Colonic Neoplasms</condition>
    <condition>Left-sided Colorectal Resection : Rectal Neoplasms</condition>
    <arm_group>
      <arm_group_label>interventional arm (use of TRIDENT system)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>use of the TRIDENT system</intervention_name>
      <description>usage of Trident System v1.0, just before the final resection, to obtain some images of the tissue oxygenation.</description>
      <arm_group_label>interventional arm (use of TRIDENT system)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient scheduled for a left-sided colorectal resection, irrespective of the surgical&#xD;
               approach (open surgery, laparoscopic surgery,) because of:&#xD;
  &#xD;
                 -  Colon cancer OR&#xD;
  &#xD;
                 -  Sigmoid diverticular disease OR&#xD;
  &#xD;
                 -  Rectal cancer&#xD;
  &#xD;
            -  All genders&#xD;
  &#xD;
            -  Age &gt; 18 years old&#xD;
  &#xD;
            -  Ability to understand the information related to the study protocol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Contraindications to anaesthesia&#xD;
  &#xD;
            -  Inability to provide a written informed consent&#xD;
  &#xD;
            -  Inclusion in a different ongoing clinical trial&#xD;
  &#xD;
            -  Emergency procedure&#xD;
  &#xD;
            -  Abdomino-perineal resection&#xD;
  &#xD;
            -  Hartmann procedure&#xD;
  &#xD;
            -  Patient is part of vulnerable population (e.g., prisoners, mentally disabled)&#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>Michele Diana, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Strasbourg</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marie Allouis</last_name>
      <phone>+33 786 480 495</phone>
      <email>EU Clinical Affairs &lt;DL-Department-ClinicalAffairs-EMEA@intusurg.com&gt;</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU Strasbourg</name>
        <address>
          <city>Strasbourg</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michele Diana, MD, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Colorectal surgery</keyword>
    <keyword>TRIDENT system</keyword>
    <keyword>Tissue oxygenation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Rectal Neoplasms</mesh_term>
      <mesh_term>Colonic Neoplasms</mesh_term>
      <mesh_term>Diverticular Diseases</mesh_term>
      <mesh_term>Diverticulum</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/NCT05973227
  org study id: 1094572-01C
  nct id: NCT05973227
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of the study is to assess the safety and technical feasibility of a new imaging
        system, used during colorectal resection surgery, named Trident in version 1.0, which could
        be used by the surgeon during colorectal procedures to obtain information on intestinal
        tissue oxygenation.
  This is a prospective, non-randomized, single center, feasibility trial. All consecutive
        patients that fulfil the inclusion/exclusion criteria will be informed about the possibility
        to be included in the present clinical investigation. Only subjects that have signed the
        study informed consent will be included in the study. The Trident System v1.0 will be used
        only during approximately 2 to 5 minutes during a precise surgical step, i.e., just before
        the final resection of the surgical specimen. Patients will be prospectively followed at 30
        days post-surgery. Data will be collected prospectively from the medical records.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery.
  time frame: 30 days FU
  description: descriptive analysis on the quality images by the engineering design team and feedback provided by clinical experts (surgeons) according to ad hoc form evaluating: 1) ergonomics aspects; 2) workflow; 3) risks of breaching sterility; 4) Speed of image acquisition.
  measure: - level of oxygenation (StO2) of the exteriorized colon before resection with the Trident System v1.0 - the level of oxygenation (StO2) provided by the system at the site chosen by the surgeon based on the clinical evaluation.
  time frame: surgery day
  description: Measurement of StO2 values at the resection site determined by the surgeon based on his clinical judgment and measurement of StO2 levels over the entire length of the colon exteriorized and visible in the field of view of the Trident System v1.0.
  arm group label: interventional arm (use of TRIDENT system)
  arm group type: Experimental
  intervention type: Device
  intervention name: use of the TRIDENT system
  description: usage of Trident System v1.0, just before the final resection, to obtain some images of the tissue oxygenation.
  arm group label: interventional arm (use of TRIDENT system)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michele Diana, MD, PhD
  role: Principal Investigator
  affiliation: CHU Strasbourg
  last name: Marie Allouis
  phone: +33 786 480 495
  email: EU Clinical Affairs <DL-Department-ClinicalAffairs-EMEA@intusurg.com>
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Rectal Neoplasms
  mesh term: Colonic Neoplasms
  mesh term: Diverticular Diseases
  mesh term: Diverticulum
  sharing ipd: No