<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/NCT03256383</url>
  </required_header>
  <id_info>
    <org_study_id>276</org_study_id>
    <nct_id>NCT03256383</nct_id>
  </id_info>
  <brief_title>Plan for Testing Fingerstick Bloods on Magellan Systems</brief_title>
  <official_title>Plan for Testing Fingerstick Bloods on Magellan Systems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Magellan Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Magellan Diagnostics</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>
      This study is to supplement our internal data that demonstrates the continued performance of&#xD;
      capillary blood samples on Magellan's lead testing systems: LeadCare II, LeadCare Ultra&#xD;
      (which have been cleared previously by FDA), and PediaStat, which is an upgraded LeadCare II&#xD;
      instrument in development.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Lead poisoning</measure>
    <time_frame>1 day</time_frame>
    <description>&gt;10ug/dL lead in whole blood is considered lead poisoning These measurements will be taken to compare the fingerstick data collected in the field with data received through reference method</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Lead Poisoning</condition>
  <arm_group>
    <arm_group_label>Adult</arm_group_label>
    <description>Patients aged 18+ years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children 7 - 17</arm_group_label>
    <description>Patients aged 7 - 17 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children &lt;7</arm_group_label>
    <description>Patients aged under 7 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lead testing</intervention_name>
    <description>Fingerstick</description>
    <arm_group_label>Adult</arm_group_label>
    <arm_group_label>Children 7 - 17</arm_group_label>
    <arm_group_label>Children &lt;7</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adults and children up to 18 years of age who are at risk of lead exposure, pregnant women&#xD;
        who are at risk of lead exposure,&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy subjects who consent to a capillary blood collection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients are not currently taking chelating agents, e.g., penicillamine, succimer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Rappo, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_contact>
    <last_name>Catherine Lufkin</last_name>
    <phone>978-248-4963</phone>
    <email>Catherine.Lufkin@magellandx.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pediatric Associates, Inc.</name>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Rappo, MD</last_name>
      <phone>508-584-1210</phone>
      <email>prappo@pediatricassociatesbrockton.com</email>
    </contact>
    <investigator>
      <last_name>Peter Rappo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pediatrics Associates, Inc</name>
      <address>
        <city>Hanson</city>
        <state>Massachusetts</state>
        <zip>02341</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Rappo, MD</last_name>
      <email>prappo@pediatricassociatesbrockton.com</email>
    </contact>
    <investigator>
      <last_name>Peter Rappo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pediatrics Associates, Inc</name>
      <address>
        <city>West Bridgewater</city>
        <state>Massachusetts</state>
        <zip>02379</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Rappo, MD</last_name>
      <phone>508-584-1210</phone>
      <email>prappo@pediatricassociatesbrockton.com</email>
    </contact>
    <investigator>
      <last_name>Peter Rappo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</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>Poisoning</mesh_term>
    <mesh_term>Lead Poisoning</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03256383/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03256383/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03256383
org study id: 276
nct id: NCT03256383
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study is to supplement our internal data that demonstrates the continued performance of
      capillary blood samples on Magellan's lead testing systems: LeadCare II, LeadCare Ultra
      (which have been cleared previously by FDA), and PediaStat, which is an upgraded LeadCare II
      instrument in development.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Lead poisoning
time frame: 1 day
description: >10ug/dL lead in whole blood is considered lead poisoning These measurements will be taken to compare the fingerstick data collected in the field with data received through reference method
arm group label: Adult
description: Patients aged 18+ years
arm group label: Children 7 - 17
description: Patients aged 7 - 17 years
arm group label: Children <7
description: Patients aged under 7 years
intervention type: Device
intervention name: Lead testing
description: Fingerstick
arm group label: Adult
arm group label: Children 7 - 17
arm group label: Children <7
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Rappo, MD
role: Principal Investigator
last name: Catherine Lufkin
phone: 978-248-4963
email: Catherine.Lufkin@magellandx.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Poisoning
mesh term: Lead Poisoning
provided document: 
provided document: 