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/NCT06004440</url>
    </required_header>
    <id_info>
      <org_study_id>IntuitiveSurgical</org_study_id>
      <nct_id>NCT06004440</nct_id>
    </id_info>
    <brief_title>Real World Registry for Use of the Ion Endoluminal System</brief_title>
    <official_title>A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System</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>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective of this study is to evaluate the performance of the Ion Endoluminal&#xD;
        System with real-world use for pulmonary lesion localization or biopsy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a single-arm, post-market, prospective, multi-center, observational study of&#xD;
        subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or&#xD;
        biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is&#xD;
        focused on evaluating the performance characteristics of the pulmonary lesion biopsy&#xD;
        procedure as evaluated by diagnostic yield.&#xD;
  &#xD;
        Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public&#xD;
        Health Service Act and 42 CFR 11.60.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">August 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2026</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>2 Years</target_duration>
    <primary_outcome>
      <measure>Primary Endpoint to Assess Diagnostic Yield</measure>
      <time_frame>Intra-procedure through the 24 month follow up period</time_frame>
      <description>Defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Secondary Endpoint to Assess Pneumothorax</measure>
      <time_frame>Intra-procedure through the 30 day follow up period</time_frame>
      <description>Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary Endpoint to Assess Bleeding</measure>
      <time_frame>Intra-procedure through the 30 day follow up period</time_frame>
      <description>Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">3000</enrollment>
    <condition>Lung Cancer</condition>
    <condition>Multiple Pulmonary Nodules</condition>
    <condition>Lung Neoplasms</condition>
    <condition>Respiratory Tract Neoplasms</condition>
    <condition>Thoracic Neoplasms</condition>
    <condition>Neoplasms by Site</condition>
    <condition>Neoplasms</condition>
    <condition>Lung Diseases</condition>
    <condition>Respiratory Tract Diseases</condition>
    <arm_group>
      <arm_group_label>Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System</arm_group_label>
      <description>Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Ion Endoluminal System</intervention_name>
      <description>Subjects will under a planned procedure with the Ion Endoluminal System</description>
      <arm_group_label>Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects scheduled for an elective pulmonary lesion biopsy or localization procedure using&#xD;
          the Ion Endoluminal System, 18 years or older&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject is 18 years or older at the time of the index procedure.&#xD;
  &#xD;
            -  Subject is a candidate for an elective, planned lung lesion localization or biopsy&#xD;
               procedure utilizing the Ion Endoluminal System.&#xD;
  &#xD;
            -  Subject able to understand and adhere to study requirements and provide informed&#xD;
               consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject is under the care of a Legally Authorized Representative (LAR) and is unable&#xD;
               to provide informed consent on their own accord.&#xD;
  &#xD;
            -  Subject is participating in an interventional research study or research study&#xD;
               investigational agents with an unknown safety profile that would interfere with&#xD;
               participation in this study.&#xD;
  &#xD;
            -  Female subjects who are pregnant or nursing at the time of the index bronchoscopy&#xD;
               procedure, as determined by standard site practices.&#xD;
  &#xD;
            -  Subjects that are incarcerated or institutionalized under court order, or other&#xD;
               vulnerable populations.&#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>Janani Reisenauer, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Michael Pritchett, DO, MPH</last_name>
      <role>Study Chair</role>
      <affiliation>FirstHealth of the Carolinas</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Heather Golden, MSc, CCRP</last_name>
      <phone>8105697006</phone>
      <email>heather.golden@intusurg.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lindsay Seibel, BSc</last_name>
      <email>Lindsay.Seibel@intusurg.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Orlando Health Orlando Regional Medical Center</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32806</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kathleen Sanders, MBA, CCRP</last_name>
        <email>Kathleen.Sanders@orlandohealth.com</email>
      </contact>
      <investigator>
        <last_name>Ali Z. Jiwani, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55902</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Karly Pierson, RN, CCRP</last_name>
        <email>Pierson.Karlyn@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Janani Reisenauer, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>FirstHealth Moore Regional Hospital</name>
        <address>
          <city>Pinehurst</city>
          <state>North Carolina</state>
          <zip>28374</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Julie Williams, PhD, MPH</last_name>
        <email>jcwilliams@firsthealth.org</email>
      </contact>
      <investigator>
        <last_name>Michael Prichett, DO, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>pulmonary biopsy</keyword>
    <keyword>pulmonary lesion localization</keyword>
    <keyword>shape sensing robotic assisted bronchoscopy</keyword>
    <keyword>ION</keyword>
    <keyword>Intuitive</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Multiple Pulmonary Nodules</mesh_term>
      <mesh_term>Neoplasms by Site</mesh_term>
      <mesh_term>Thoracic Neoplasms</mesh_term>
      <mesh_term>Respiratory Tract Neoplasms</mesh_term>
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Respiratory Tract Diseases</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/NCT06004440
  org study id: IntuitiveSurgical
  nct id: NCT06004440
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The primary objective of this study is to evaluate the performance of the Ion Endoluminal
        System with real-world use for pulmonary lesion localization or biopsy.
  This study is a single-arm, post-market, prospective, multi-center, observational study of
        subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or
        biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is
        focused on evaluating the performance characteristics of the pulmonary lesion biopsy
        procedure as evaluated by diagnostic yield.
  
        Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public
        Health Service Act and 42 CFR 11.60.
  observational model: Cohort
  time perspective: Prospective
  measure: Primary Endpoint to Assess Diagnostic Yield
  time frame: Intra-procedure through the 24 month follow up period
  description: Defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.
  measure: Secondary Endpoint to Assess Pneumothorax
  time frame: Intra-procedure through the 30 day follow up period
  description: Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention
  measure: Secondary Endpoint to Assess Bleeding
  time frame: Intra-procedure through the 30 day follow up period
  description: Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale
  arm group label: Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System
  description: Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.
  intervention type: Device
  intervention name: Ion Endoluminal System
  description: Subjects will under a planned procedure with the Ion Endoluminal System
  arm group label: Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Janani Reisenauer, MD
  role: Study Chair
  affiliation: Mayo Clinic
  last name: Michael Pritchett, DO, MPH
  role: Study Chair
  affiliation: FirstHealth of the Carolinas
  last name: Heather Golden, MSc, CCRP
  phone: 8105697006
  email: heather.golden@intusurg.com
  last name: Lindsay Seibel, BSc
  email: Lindsay.Seibel@intusurg.com
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Lung Neoplasms
  mesh term: Multiple Pulmonary Nodules
  mesh term: Neoplasms by Site
  mesh term: Thoracic Neoplasms
  mesh term: Respiratory Tract Neoplasms
  mesh term: Lung Diseases
  mesh term: Respiratory Tract Diseases
  sharing ipd: No