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/NCT06037837</url>
    </required_header>
    <id_info>
      <org_study_id>23-094</org_study_id>
      <nct_id>NCT06037837</nct_id>
    </id_info>
    <brief_title>Improving Surgeon Performance Measures for Robot-Assisted Surgery</brief_title>
    <official_title>Generalized Robotic Skills Assessment Using Machine Learning-Based Analysis Across Multiple Surgical Specialties</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Memorial Sloan Kettering Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Memorial Sloan Kettering Cancer Center</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to develop new tools to understand surgeon performance to&#xD;
        improve surgical training and participant outcomes after surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 24, 2023</start_date>
    <completion_date type="Anticipated">August 24, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 24, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Correlation of Automated Performance Metrics to surgeon experience</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>For the primary objective, we will capture Automated Performance Metrics/APMs and will determine the association between these and other metrics and surgeon experience, which will be used to construct validation.&#xD;
  APMs that will be used in the study:&#xD;
  Time Metrics&#xD;
  Camera Metrics&#xD;
  Instrument Metrics&#xD;
  System Metrics&#xD;
  Articulation Metrics</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Surgery</condition>
    <arm_group>
      <arm_group_label>Robotic surgeons</arm_group_label>
      <description>Participants will be robotic surgeons in urologic, gynecologic, colorectal, hepatobiliary, gastric, and thoracic surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Robotic Surgery</intervention_name>
      <description>Surgeons will perform and participants will undergo robotic surgery according to the standard of care. No additional interventions will be performed on participating participants.</description>
      <arm_group_label>Robotic surgeons</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Surgeons who meet the inclusion criteria will be approached by the study team for&#xD;
          participation in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Surgeon inclusion criteria:&#xD;
  &#xD;
            -  Performs robotic surgery for candidate procedures&#xD;
  &#xD;
            -  Performs candidate procedures that are frequently performed by at least three surgeons&#xD;
               (to ensure the ability to make adequate comparisons)&#xD;
  &#xD;
            -  Agrees to participate in the study&#xD;
  &#xD;
          Patient inclusion criteria:&#xD;
  &#xD;
            -  Aged 18 years or older&#xD;
  &#xD;
            -  Scheduled to undergo a robot-assisted surgical procedure involving the prostate,&#xD;
               kidney, bladder, colon, pancreas, gallbladder, stomach, uterus, or lung&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patient exclusion criteria:&#xD;
  &#xD;
            -  Scheduled to undergo multiple panel procedures&#xD;
  &#xD;
            -  Scheduled to undergo hybrid procedures involving open and robot-assisted techniques&#xD;
  &#xD;
               o Hybrid procedures will involve multiple surgeons from different subspecialties,&#xD;
               include certain rare steps, and require the surgeons' improvisation to complete such&#xD;
               procedures safely; to avoid data heterogeneity, we have elected to exclude such&#xD;
               procedures&#xD;
  &#xD;
            -  Refusal to consent to data capture during the procedure&#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>Alvin Goh, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alvin Goh, MD</last_name>
      <phone>646-422-4667</phone>
      <email>goha@mskcc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kevin Soares, MD</last_name>
      <phone>212-639-3195</phone>
      <email>soaresk@mskcc.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)</name>
        <address>
          <city>Basking Ridge</city>
          <state>New Jersey</state>
          <zip>07920</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alvin Goh, MD</last_name>
        <phone>646-422-4667</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Monmouth (Limited protocol activities)</name>
        <address>
          <city>Middletown</city>
          <state>New Jersey</state>
          <zip>07748</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alvin Goh, MD</last_name>
        <phone>646-422-4667</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Bergen (Limited Protocol Activities)</name>
        <address>
          <city>Montvale</city>
          <state>New Jersey</state>
          <zip>07645</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alvin Goh, MD</last_name>
        <phone>646-422-4667</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )</name>
        <address>
          <city>Commack</city>
          <state>New York</state>
          <zip>11725</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alvin Goh, MD</last_name>
        <phone>646-422-4667</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Westchester (Limited Protocol Activities)</name>
        <address>
          <city>Harrison</city>
          <state>New York</state>
          <zip>10604</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alvin Goh, MD</last_name>
        <phone>646-422-4667</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center (All protocol activites)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alvin Goh, MD</last_name>
        <phone>646-422-4667</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Nassau (Limited Protocol Activites)</name>
        <address>
          <city>Rockville Centre</city>
          <state>New York</state>
          <zip>11553</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alvin Goh, MD</last_name>
        <phone>646-422-4667</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mskcc.org</url>
      <description>Memorial Sloan Kettering Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Robot assisted surgical procedure</keyword>
    <keyword>robotic surgery</keyword>
    <keyword>prostate surgery</keyword>
    <keyword>kidney surgery</keyword>
    <keyword>bladder surgery</keyword>
    <keyword>colon surgery</keyword>
    <keyword>pancreas surgery</keyword>
    <keyword>gallbladder surgery</keyword>
    <keyword>stomach surgery</keyword>
    <keyword>uterus surgery</keyword>
    <keyword>lung surgery</keyword>
    <keyword>Memorial Sloan Kettering Cancer Center</keyword>
    <keyword>23-094</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
    </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/NCT06037837
  org study id: 23-094
  nct id: NCT06037837
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to develop new tools to understand surgeon performance to
        improve surgical training and participant outcomes after surgery.
  observational model: Cohort
  time perspective: Prospective
  measure: Correlation of Automated Performance Metrics to surgeon experience
  time frame: Up to 2 years
  description: For the primary objective, we will capture Automated Performance Metrics/APMs and will determine the association between these and other metrics and surgeon experience, which will be used to construct validation.
  APMs that will be used in the study:
  Time Metrics
  Camera Metrics
  Instrument Metrics
  System Metrics
  Articulation Metrics
  arm group label: Robotic surgeons
  description: Participants will be robotic surgeons in urologic, gynecologic, colorectal, hepatobiliary, gastric, and thoracic surgery
  intervention type: Procedure
  intervention name: Robotic Surgery
  description: Surgeons will perform and participants will undergo robotic surgery according to the standard of care. No additional interventions will be performed on participating participants.
  arm group label: Robotic surgeons
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alvin Goh, MD
  role: Principal Investigator
  affiliation: Memorial Sloan Kettering Cancer Center
  last name: Alvin Goh, MD
  phone: 646-422-4667
  email: goha@mskcc.org
  last name: Kevin Soares, MD
  phone: 212-639-3195
  email: soaresk@mskcc.org
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: http://www.mskcc.org
  description: Memorial Sloan Kettering Cancer Center
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.