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/NCT06035952</url>
    </required_header>
    <id_info>
      <org_study_id>54101</org_study_id>
      <nct_id>NCT06035952</nct_id>
    </id_info>
    <brief_title>Study of 3D Scanning for Adolescent Scoliosis</brief_title>
    <official_title>Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NSite Medical</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NSite Medical</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_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators aim to validate three-dimensional topographical scanning technology as a&#xD;
        tool for evaluation of scoliosis. Through the incorporation of 3D topographical technology in&#xD;
        the measurement of deformity, the investigators hope to validate a novel approach to quantify&#xD;
        deformity progression and provide an accessible alternative to traditional radiographic&#xD;
        workup.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study design will be prospective observational. Patients 10 to 18 years old being&#xD;
        evaluated or followed for scoliosis will be included. Those unable to complete the consent&#xD;
        and assent processes will not be enrolled. Members of the research team will review the&#xD;
        clinic schedule through EPIC each week to identify eligible patients. Member of the patient's&#xD;
        care team, such as the physician, will introduce the study to the patient. If the patient and&#xD;
        the patient's caregivers are interested in learning more and/or participating, a member of&#xD;
        the research team will provide study-related information and obtain informed consent via&#xD;
        written or electronic consent, assent, and, if necessary, short form consent.&#xD;
  &#xD;
        If a patient consents to participate, members of the research team will conduct the 3D&#xD;
        topographical scan in a private room in the clinic. This involves 360 degree scans using a&#xD;
        smartphone camera. Participants will also receive any standard of care x-rays during the&#xD;
        visit. The investigators will then analyze the ability of the 3D smartphone scan to estimate&#xD;
        the Cobb Angle measured on the X-ray, to infer the magnitude of the scoliosis deformity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</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>Accuracy of scanning device to predict clinically significant Cobb Angle</measure>
      <time_frame>Through study completion, an average of 3 months</time_frame>
      <description>The primary study endpoint, or primary outcome, is whether the 3D scan's predicted probability of clinically significant Cobb angle correlates with the ground truth radiograph obtained Cobb angle at the defined rate. The percentage (%) of patient scans with predicted probabilities that correlate with ground truth results will be reported.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Repeatability of 3D scan analysis</measure>
      <time_frame>Within 48 hours</time_frame>
      <description>After the 3D scan is obtained, several personnel will align the scan relative to grid coordinates, and place a region of interest on the back of the scan. Measurements will be performed which will generate an asymmetry value, which is used to assess Cobb Angle correlation. The investigators will determine the repeatability of this manual scan assessment process.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Scoliosis</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <description>This study will have one cohort. This group of patients will undergo 3D scanning with a smartphone, and will also have standard of care diagnostics, such as an X-ray.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>3D topographical scan</intervention_name>
      <description>Subjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will include children and adolescent patients 10 to 18 years old who&#xD;
          present to a pediatric orthopedic clinic for scoliosis evaluation. This age range was&#xD;
          chosen as it is the age range in which Adolescent Idiopathic Scoliosis commonly appears,&#xD;
          and the device is intended for screening for this condition.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages 10 and 18 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Scoliosis caused by another condition (e.g., secondary scoliosis)&#xD;
  &#xD;
            -  Parents/guardians unable to consent&#xD;
  &#xD;
            -  English is not the primary language (to avoid miscommunication)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kali Tileston, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael J. Gardner, MD</last_name>
      <phone>9175846909</phone>
      <email>mike@nsitemedical.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Stanford University School of Medicine</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94063</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kali Tileston</last_name>
        <phone>650-723-5243</phone>
        <email>kluker@stanford.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Duke University</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27708</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anthony Catanzano, MD</last_name>
        <phone>919-613-7797</phone>
        <email>anthony.catanzano@duke.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>scoliosis</keyword>
    <keyword>topographical scanning</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Scoliosis</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/NCT06035952
  org study id: 54101
  nct id: NCT06035952
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The investigators aim to validate three-dimensional topographical scanning technology as a
        tool for evaluation of scoliosis. Through the incorporation of 3D topographical technology in
        the measurement of deformity, the investigators hope to validate a novel approach to quantify
        deformity progression and provide an accessible alternative to traditional radiographic
        workup.
  The study design will be prospective observational. Patients 10 to 18 years old being
        evaluated or followed for scoliosis will be included. Those unable to complete the consent
        and assent processes will not be enrolled. Members of the research team will review the
        clinic schedule through EPIC each week to identify eligible patients. Member of the patient's
        care team, such as the physician, will introduce the study to the patient. If the patient and
        the patient's caregivers are interested in learning more and/or participating, a member of
        the research team will provide study-related information and obtain informed consent via
        written or electronic consent, assent, and, if necessary, short form consent.
  
        If a patient consents to participate, members of the research team will conduct the 3D
        topographical scan in a private room in the clinic. This involves 360 degree scans using a
        smartphone camera. Participants will also receive any standard of care x-rays during the
        visit. The investigators will then analyze the ability of the 3D smartphone scan to estimate
        the Cobb Angle measured on the X-ray, to infer the magnitude of the scoliosis deformity.
  observational model: Cohort
  time perspective: Prospective
  measure: Accuracy of scanning device to predict clinically significant Cobb Angle
  time frame: Through study completion, an average of 3 months
  description: The primary study endpoint, or primary outcome, is whether the 3D scan's predicted probability of clinically significant Cobb angle correlates with the ground truth radiograph obtained Cobb angle at the defined rate. The percentage (%) of patient scans with predicted probabilities that correlate with ground truth results will be reported.
  measure: Repeatability of 3D scan analysis
  time frame: Within 48 hours
  description: After the 3D scan is obtained, several personnel will align the scan relative to grid coordinates, and place a region of interest on the back of the scan. Measurements will be performed which will generate an asymmetry value, which is used to assess Cobb Angle correlation. The investigators will determine the repeatability of this manual scan assessment process.
  arm group label: Intervention
  description: This study will have one cohort. This group of patients will undergo 3D scanning with a smartphone, and will also have standard of care diagnostics, such as an X-ray.
  intervention type: Diagnostic Test
  intervention name: 3D topographical scan
  description: Subjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone.
  arm group label: Intervention
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kali Tileston, MD
  role: Principal Investigator
  affiliation: Stanford University
  last name: Michael J. Gardner, MD
  phone: 9175846909
  email: mike@nsitemedical.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Scoliosis
  sharing ipd: No