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/NCT05964166</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00003295</org_study_id>
      <nct_id>NCT05964166</nct_id>
    </id_info>
    <brief_title>Tetragraph® Monitor: Tolerance of Preoperative Placement</brief_title>
    <official_title>Tetragraph® Monitor: Tolerance of Preoperative Placement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Joseph D. Tobias</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nationwide Children's Hospital</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>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, non-blinded, single arm study. The primary objective of this study is&#xD;
        to evaluate the tolerance to preoperative placement of the adhesive sensor for the&#xD;
        Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">May 31, 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Tolerance to preop placement as assessed by Likert scale</measure>
      <time_frame>30 mins. prior to surgery</time_frame>
      <description>Patient's tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by using a 10-point Likert scale with 0=very badly/pulled sensor off and 10=very well/left sensor alone.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>EMG changes</measure>
      <time_frame>During surgery</time_frame>
      <description>Changes in the amplitude of the evoked response of the muscles.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Surgery</condition>
    <arm_group>
      <arm_group_label>Tetragraph</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>TetraGraph NMT Monitor</intervention_name>
      <description>TetraGraph is a unique, EMG=based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.</description>
      <arm_group_label>Tetragraph</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients requiring anesthetic care and use of neuromuscular blockade&#xD;
  &#xD;
            2. Age ≤ 12 years&#xD;
  &#xD;
            3. ASA 1-4&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of a peripheral neurologic or neuropathic disorder&#xD;
  &#xD;
            2. Upper extremity cannot be used for TOF monitoring&#xD;
  &#xD;
            3. Undergoing a surgical procedure in which neuromuscular blockade is not required&#xD;
  &#xD;
            4. Patient is edematous&#xD;
  &#xD;
            5. Patients with significant behavioral or neurocognitive issues which affect behavior&#xD;
               and impact the ability to place the sensor&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Months</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Nationwide Children's Hospital</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43205</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 2, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
      <investigator_full_name>Joseph D. Tobias</investigator_full_name>
      <investigator_title>Chief of Anesthesiology &amp; Pain Medicine</investigator_title>
    </responsible_party>
    <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/NCT05964166
  org study id: STUDY00003295
  nct id: NCT05964166
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This is a prospective, non-blinded, single arm study. The primary objective of this study is
        to evaluate the tolerance to preoperative placement of the adhesive sensor for the
        Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Tolerance to preop placement as assessed by Likert scale
  time frame: 30 mins. prior to surgery
  description: Patient's tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor will be assessed by using a 10-point Likert scale with 0=very badly/pulled sensor off and 10=very well/left sensor alone.
  measure: EMG changes
  time frame: During surgery
  description: Changes in the amplitude of the evoked response of the muscles.
  arm group label: Tetragraph
  arm group type: Experimental
  intervention type: Device
  intervention name: TetraGraph NMT Monitor
  description: TetraGraph is a unique, EMG=based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
  arm group label: Tetragraph
  criteria: 
  gender: All
  minimum age: 3 Months
  maximum age: 12 Years
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Nationwide Children's Hospital
  investigator full name: Joseph D. Tobias
  investigator title: Chief of Anesthesiology & Pain Medicine
  sharing ipd: No