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/NCT06039085</url>
    </required_header>
    <id_info>
      <org_study_id>02001660</org_study_id>
      <nct_id>NCT06039085</nct_id>
    </id_info>
    <brief_title>Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment</brief_title>
    <official_title>Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ryan J. Halter</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Dartmouth College</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Dartmouth-Hitchcock Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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 research will study a custom device developed to detect if any prostate cancer tissue is&#xD;
        left behind when the prostate is removed. This device is called an Electrical Impedance&#xD;
        Imaging (EII) probe.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Two hundred men will be recruited to participate in this trial. Consent will be obtained from&#xD;
        all participating men prior to surgery.&#xD;
  &#xD;
        The trial will consist of recording EII data from:&#xD;
  &#xD;
          1. In vivo pelvic floor and peri-prostatic tissues remaining after the prostate has been&#xD;
             resected&#xD;
  &#xD;
          2. Resected ex vivo prostate following extraction from the abdomen (in the OR)&#xD;
  &#xD;
          3. Resected ex vivo prostate when transferred to Pathology, post-RARP&#xD;
  &#xD;
        The study team will also track post-surgical complications due to the study's technology&#xD;
        (e.g., infection) and additional time required to deploy the study technology used to assess&#xD;
        feasibility of clinical integration of the EII device. Post-RARP pathological assessment of&#xD;
        margin tissues will be used to train and evaluate the study's classification schemes for&#xD;
        identifying Positive Surgical Margin (PSMs).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>EI signatures of +/- surgical margins during prostate surgery</measure>
      <time_frame>2023-2025</time_frame>
      <description>Outcome measures will include how significantly different electrical impedance signatures are between impedance recordings of positive and negative surgical margins as acquired during prostate surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety of EI sensing in vivo electrical sensing</measure>
      <time_frame>2023-2025</time_frame>
      <description>Secondary outcome measures will include number of study-related adverse events documented.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy of EI sensing in vivo electrical sensing</measure>
      <time_frame>2023-2025</time_frame>
      <description>Tertiary outcome measures will include classification accuracy of EI-based surgical margin assessment</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Prostate Cancer</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>custom device to demonstrate a significant difference in electrical impedance signatures</intervention_name>
      <description>Custom device will be used to measure electrical impedance signatures.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Men with a diagnosis of prostate cancer who require surgery.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Clinical diagnosis of prostate cancer requiring RARP.&#xD;
  &#xD;
            2. Ability to understand and the willingness to sign a written informed consent document.&#xD;
  &#xD;
            3. Age ≥ 18 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Adults with implanted electrical devices such as pacemakers&#xD;
  &#xD;
            2. Prisoners&#xD;
  &#xD;
            3. Adults with impaired decision-making capacity&#xD;
  &#xD;
            4. Any condition for which, in the opinion of the investigator, contraindicates study&#xD;
               participation.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Participants will be biologically male due to this study's focus on prostate cancer</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ryan J Halter, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dartmouth-Hitchcock, Manchester</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ryan J Halter, PhD</last_name>
      <phone>(603) 646-0773</phone>
      <email>Ryan.J.Halter@dartmouth.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 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-Investigator</responsible_party_type>
      <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
      <investigator_full_name>Ryan J. Halter</investigator_full_name>
      <investigator_title>Investigator and Regulatory Sponsor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</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/NCT06039085
  org study id: 02001660
  nct id: NCT06039085
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This research will study a custom device developed to detect if any prostate cancer tissue is
        left behind when the prostate is removed. This device is called an Electrical Impedance
        Imaging (EII) probe.
  Two hundred men will be recruited to participate in this trial. Consent will be obtained from
        all participating men prior to surgery.
  
        The trial will consist of recording EII data from:
  
          1. In vivo pelvic floor and peri-prostatic tissues remaining after the prostate has been
             resected
  
          2. Resected ex vivo prostate following extraction from the abdomen (in the OR)
  
          3. Resected ex vivo prostate when transferred to Pathology, post-RARP
  
        The study team will also track post-surgical complications due to the study's technology
        (e.g., infection) and additional time required to deploy the study technology used to assess
        feasibility of clinical integration of the EII device. Post-RARP pathological assessment of
        margin tissues will be used to train and evaluate the study's classification schemes for
        identifying Positive Surgical Margin (PSMs).
  observational model: Cohort
  time perspective: Prospective
  measure: EI signatures of +/- surgical margins during prostate surgery
  time frame: 2023-2025
  description: Outcome measures will include how significantly different electrical impedance signatures are between impedance recordings of positive and negative surgical margins as acquired during prostate surgery.
  measure: Safety of EI sensing in vivo electrical sensing
  time frame: 2023-2025
  description: Secondary outcome measures will include number of study-related adverse events documented.
  measure: Efficacy of EI sensing in vivo electrical sensing
  time frame: 2023-2025
  description: Tertiary outcome measures will include classification accuracy of EI-based surgical margin assessment
  intervention type: Device
  intervention name: custom device to demonstrate a significant difference in electrical impedance signatures
  description: Custom device will be used to measure electrical impedance signatures.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Participants will be biologically male due to this study's focus on prostate cancer
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ryan J Halter, PhD
  role: Principal Investigator
  affiliation: Dartmouth-Hitchcock, Manchester
  last name: Ryan J Halter, PhD
  phone: (603) 646-0773
  email: Ryan.J.Halter@dartmouth.edu
  responsible party type: Sponsor-Investigator
  investigator affiliation: Dartmouth-Hitchcock Medical Center
  investigator full name: Ryan J. Halter
  investigator title: Investigator and Regulatory Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: No