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/NCT06040697</url>
    </required_header>
    <id_info>
      <org_study_id>2023-02</org_study_id>
      <nct_id>NCT06040697</nct_id>
    </id_info>
    <brief_title>Formative Usability Assessment of Wireless Thermal Anisotropy Devices</brief_title>
    <official_title>Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rhaeos, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rhaeos, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Measurements of shunt flow will be performed non-invasively. This study will generate&#xD;
        usability data via observed tasks and comprehension questions to enable future device design&#xD;
        improvements.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Exploratory device usability feedback</measure>
      <time_frame>2 hours</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">145</enrollment>
    <condition>Hydrocephalus</condition>
    <arm_group>
      <arm_group_label>Usability Assessment Cohort</arm_group_label>
      <description>No interventions administered. Device usability assessment only.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Thermal Anisotropy</intervention_name>
      <description>Usability assessment observation.</description>
      <arm_group_label>Usability Assessment Cohort</arm_group_label>
      <other_name>FlowSense</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects with an existing Cerebrospinal Fluid (CSF) shunt&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Existing ventricular CSF shunt with a region of intact skin overlying the shunt&#xD;
               catheter appropriate in size for application of the study device&#xD;
  &#xD;
            2. Signed informed consent by subject or a parent, legal guardian, health care agent, or&#xD;
               surrogate decision maker (according to local statutes)&#xD;
  &#xD;
            3. Subject or caregiver can clearly communicate and document information in English&#xD;
  &#xD;
            4. Verbal assent by minors 12 years of age and older who can understand the study and&#xD;
               communicate their decision&#xD;
  &#xD;
            5. Subject is at least 5 years old but not more than 80 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Presence of an interfering open wound in the device application region&#xD;
  &#xD;
            2. Subject-reported history of adverse skin reactions to adhesives&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <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</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hydrocephalus</mesh_term>
    </condition_browse>
    <!-- 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/NCT06040697
  org study id: 2023-02
  nct id: NCT06040697
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  Measurements of shunt flow will be performed non-invasively. This study will generate
        usability data via observed tasks and comprehension questions to enable future device design
        improvements.
  observational model: Other
  time perspective: Other
  measure: Exploratory device usability feedback
  time frame: 2 hours
  arm group label: Usability Assessment Cohort
  description: No interventions administered. Device usability assessment only.
  intervention type: Device
  intervention name: Thermal Anisotropy
  description: Usability assessment observation.
  arm group label: Usability Assessment Cohort
  other name: FlowSense
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor
  mesh term: Hydrocephalus