<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/NCT03028090</url>
  </required_header>
  <id_info>
    <org_study_id>BAS-13-001</org_study_id>
    <nct_id>NCT03028090</nct_id>
  </id_info>
  <brief_title>Study to Assess Electrocardiogram Waveforms Produced Through the Utilization of the Sherlock 3CG™ Tip Confirmation System</brief_title>
  <acronym>MODUS</acronym>
  <official_title>A Two-Arm Prospective, Multi-Centered Study to Assess Electrocardiogram Waveforms Produced Through the Utilization of the Sherlock 3CG™ Tip Confirmation System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>C. R. Bard</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>C. R. Bard</source>
  <brief_summary>
    <textblock>
      This study was to gather real-time ECG data through the use of the SHERLOCK 3CG™ Tip&#xD;
      Confirmation System (TCS), an electrocardiogram (ECG)-based peripherally-inserted central&#xD;
      catheter (PICC) tip confirmation technology. The study was to promote the development of a&#xD;
      software package (MODUS) that can accurately define the maximum P-wave on an ECG waveform.&#xD;
      All study participants received PICCs as their standard of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully integrated magnetic tracking and&#xD;
      ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and&#xD;
      is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement&#xD;
      confirmation in adult patients.&#xD;
&#xD;
      In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for&#xD;
      the clinician, Bard Access Systems, Inc. developed a software package, MODUS, which can&#xD;
      accurately define the maximum p-wave on an ECG waveform. This software provides visual and/or&#xD;
      audio queues to notify the PICC placer of the location of the tip of the PICC relative to the&#xD;
      cavoatrial junction of the patient.&#xD;
&#xD;
      Subjects who required bedside PICC placement as standard of care and met eligibility criteria&#xD;
      were enrolled. The software package was not used in the guidance or placement of the PICC&#xD;
      tip. PICCs were placed per standard of care procedure using anthropometric measurements with&#xD;
      the SHERLOCK 3CG™ TCS System. Data from the placements was sent back to Bard for analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percent agreement between maximum P-wave assessments of PICC nurse clinicians and the MODUS software during PICC insertion</measure>
    <time_frame>The PICC insertion procedure is 60-90 mins in duration</time_frame>
    <description>The measurement used will be percent agreement between clinician and MODUS software. Agreement of 95% between the nurse clinician and software assessments will be used to validate the study hypothesis.</description>
  </primary_outcome>
  <enrollment type="Actual">182</enrollment>
  <condition>Indication for Peripheral Intravenous Catheterization</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SHERLOCK 3CG™ Tip Confirmation System with MODUS Software</intervention_name>
    <description>The SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients. In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for the clinician, Bard Access Systems, Inc. is developing MODUS, a software package.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population was to be comprised of a sufficient number of subjects so that a&#xD;
        minimum of 201 subjects completed the study, but no more than 250 subjects were to be&#xD;
        enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A subject must have met the following criteria to be enrolled in the study:&#xD;
&#xD;
          1. Male or female, age ≥ 21 years&#xD;
&#xD;
          2. Subject required PICC placement as part of standard of care&#xD;
&#xD;
          3. Subject had signed an Informed Consent Form (ICF) or had an ICF signed by the&#xD;
             subject's legally authorized representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A subject was excluded if any of the following criteria were met:&#xD;
&#xD;
               1. Subject had a contraindication to PICC placement as listed in the Instructions&#xD;
                  for Use (IFU)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gina Gilbert, BSN</last_name>
    <role>Study Director</role>
    <affiliation>CR Bard</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Health System</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethesda North Hospital</name>
      <address>
        <city>Montgomery</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03028090
org study id: BAS-13-001
nct id: NCT03028090
lead sponsor: 
This study was to gather real-time ECG data through the use of the SHERLOCK 3CG™ Tip
      Confirmation System (TCS), an electrocardiogram (ECG)-based peripherally-inserted central
      catheter (PICC) tip confirmation technology. The study was to promote the development of a
      software package (MODUS) that can accurately define the maximum P-wave on an ECG waveform.
      All study participants received PICCs as their standard of care.
The SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully integrated magnetic tracking and
      ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and
      is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement
      confirmation in adult patients.

      In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for
      the clinician, Bard Access Systems, Inc. developed a software package, MODUS, which can
      accurately define the maximum p-wave on an ECG waveform. This software provides visual and/or
      audio queues to notify the PICC placer of the location of the tip of the PICC relative to the
      cavoatrial junction of the patient.

      Subjects who required bedside PICC placement as standard of care and met eligibility criteria
      were enrolled. The software package was not used in the guidance or placement of the PICC
      tip. PICCs were placed per standard of care procedure using anthropometric measurements with
      the SHERLOCK 3CG™ TCS System. Data from the placements was sent back to Bard for analysis.
observational model: Case-Only
time perspective: Prospective
measure: Percent agreement between maximum P-wave assessments of PICC nurse clinicians and the MODUS software during PICC insertion
time frame: The PICC insertion procedure is 60-90 mins in duration
description: The measurement used will be percent agreement between clinician and MODUS software. Agreement of 95% between the nurse clinician and software assessments will be used to validate the study hypothesis.
intervention type: Device
intervention name: SHERLOCK 3CG™ Tip Confirmation System with MODUS Software
description: The SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients. In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for the clinician, Bard Access Systems, Inc. is developing MODUS, a software package.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Gina Gilbert, BSN
role: Study Director
affiliation: CR Bard
facility: 
facility: 
country: United States
responsible party type: Sponsor