<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/NCT03288766</url>
  </required_header>
  <id_info>
    <org_study_id>BAS-14-003</org_study_id>
    <nct_id>NCT03288766</nct_id>
  </id_info>
  <brief_title>SHERLOCK 3CG™ Diamond Tip Confirmation System</brief_title>
  <acronym>MODUS II</acronym>
  <official_title>A Single-Arm Prospective, Multi-Centered Study to Assess the SHERLOCK 3CG™ Diamond 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>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a single-arm, prospective, multi-center study to assess clinical performance of&#xD;
      the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming&#xD;
      correct tip position of peripherally inserted central catheters (PICCs) in adult subjects&#xD;
      with altered cardiac rhythm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is intended to confirm the accuracy of the SHERLOCK 3CG™ Diamond TCS with the&#xD;
      addition of MODUS II (SLM2) software to eliminate the need for post-procedural chest x-ray&#xD;
      (CXR) in adult subjects with cardiac abnormalities that alter presentation of the P-wave.&#xD;
      Atrial fibrillation will be the primary target while data on pacemaker driven rhythms and&#xD;
      other arrhythmia types will also be collected to explore overall performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">April 19, 2018</start_date>
  <completion_date type="Actual">June 15, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 2021</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>Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2</measure>
    <time_frame>The PICC insertion procedure is 60-90 mins in duration</time_frame>
    <description>Tip positioning is determined at bedside by the software via the Green Diamond Indicator (GDI+) and confirmed by CXR. PICC tip placement will be considered successful if it is determined to be in the lower 1/3 of the SVC or in the CAJ by an independent, blinded radiologist judging position retrospectively against pre-specified anatomical criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2 in the absence of a GDI</measure>
    <time_frame>The PICC insertion procedure is 60-90 mins in duration</time_frame>
    <description>It is expected there will be some cases where the MODUS II software may fail to present a Green Diamond Indicator (GDI-). In the absence of a GDI, tip positioning is determined at bedside using magnetic tracking and external measurement per hospital protocol, with CXR required for tip confirmation. PICC tip placement will be considered successful if it is determined to be in the lower 1/3 of the SVC or in the CAJ by an independent, blinded radiologist judging position retrospectively against pre-specified anatomical criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent agreement between the site readings of the CXR (standard of care) versus those completed by an independent, blinded radiologist</measure>
    <time_frame>The PICC insertion procedure is 60-90 mins in duration</time_frame>
    <description>An independent, blinded radiologist will judge PICC tip position retrospectively against pre-specified anatomical criteria compared with findings of the SLM2.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">232</enrollment>
  <condition>Indication for Peripheral Intravenous Catheterization</condition>
  <condition>Atrial Flutter</condition>
  <condition>Premature Atrial Contraction</condition>
  <condition>Premature Ventricular Contraction</condition>
  <condition>Premature Junctional Contraction</condition>
  <condition>Tachycardia</condition>
  <condition>Atrioventricular Block</condition>
  <condition>Bundle-Branch Block</condition>
  <arm_group>
    <arm_group_label>PICC Placement with Study Device</arm_group_label>
    <description>PICC Placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software</intervention_name>
    <description>The SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) is an FDA-cleared fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology, indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients without any alterations of cardiac rhythms that change the normal presentation of the P-wave. A software package, MODUS II, has been developed to accurately analyze the entire ECG complex and identify the correct placement of the PICC tip based on a patient's individual ECG, in the absence of an easily identifiable P-wave. This software system is designed to provide visual and/or audio cues to notify the PICC placer of the location of the PICC tip relative to the cavoatrial junction (CAJ) of the patient.</description>
    <arm_group_label>PICC Placement with Study Device</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be adult males or females ≥ 21 years of age with identifiable alterations of&#xD;
        cardiac rhythm. For this study, altered cardiac rhythm is defined as any condition that&#xD;
        does not have a P-wave on ECG.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, ≥ 21 years of age with altered cardiac rhythm (no recognizable P-wave&#xD;
             on standard ECG) with diagnosis of specific arrhythmia type or identification of&#xD;
             pacemaker driven rhythms as defined below:&#xD;
&#xD;
               1. Atrial fibrillation with history of diagnosis per 12-lead ECG in medical record&#xD;
                  or diagnosed via bedside telemetry by study team RN at assessment, or&#xD;
&#xD;
               2. All other arrhythmias (including but not limited to atrial flutter, PAC, PVC,&#xD;
                  PJC, tachycardia, AV Block, BB Block) with history of diagnosis per 12-lead ECG&#xD;
                  in medical record or diagnosed via bedside telemetry by cardiac unit RN at&#xD;
                  assessment, or retrospectively by site cardiologist, or&#xD;
&#xD;
               3. Pacemaker driven rhythm with temporary or permanent pacemaker device in place;&#xD;
&#xD;
          -  Subject requires PICC placement as part of standard of care;&#xD;
&#xD;
          -  Subject or Legally Authorized Representative (LAR) has signed an Informed Consent Form&#xD;
             (ICF).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a contraindication to PICC placement as listed in the Instructions for Use&#xD;
             (IFU) to include:&#xD;
&#xD;
               1. The presence of bacteremia or septicemia (known or suspected),&#xD;
&#xD;
               2. The patient's body size is insufficient to accommodate the size of the implanted&#xD;
                  device,&#xD;
&#xD;
               3. The patient is known or is suspected to be allergic to materials contained in the&#xD;
                  device,&#xD;
&#xD;
               4. Past irradiation of prospective insertion site,&#xD;
&#xD;
               5. Previous episodes of venous thrombosis or vascular surgical procedures at the&#xD;
                  prospective placement site,&#xD;
&#xD;
               6. Local tissue factors will prevent proper device stabilization and/or access;&#xD;
&#xD;
          -  Subjects who previously had a PICC in place and require a PICC exchange;&#xD;
&#xD;
          -  Subject has presence of active resting tremor (i.e. Parkinson's, Multiple Sclerosis,&#xD;
             etc.) deemed by Investigator to have potential impact on procedure accuracy;&#xD;
&#xD;
          -  Subjects who are pregnant or think they may be pregnant.&#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>Rushil Sankpal</last_name>
    <role>Study Director</role>
    <affiliation>Becton Dickinson</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Summerlin Hospital and Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moses Cone Hospital</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vidant Medical Center</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart Medical Center</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J.W. Ruby Memorial Hospital</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine Coast University Hospital</name>
      <address>
        <city>Birtinya</city>
        <state>Queensland</state>
        <zip>4575</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fiona Stanley Hospital</name>
      <address>
        <city>Murdoch</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</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>Premature Birth</mesh_term>
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Atrial Flutter</mesh_term>
    <mesh_term>Bundle-Branch Block</mesh_term>
    <mesh_term>Atrioventricular Block</mesh_term>
    <mesh_term>Ventricular Premature Complexes</mesh_term>
    <mesh_term>Atrial Premature Complexes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03288766
org study id: BAS-14-003
nct id: NCT03288766
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a single-arm, prospective, multi-center study to assess clinical performance of
      the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming
      correct tip position of peripherally inserted central catheters (PICCs) in adult subjects
      with altered cardiac rhythm.
This study is intended to confirm the accuracy of the SHERLOCK 3CG™ Diamond TCS with the
      addition of MODUS II (SLM2) software to eliminate the need for post-procedural chest x-ray
      (CXR) in adult subjects with cardiac abnormalities that alter presentation of the P-wave.
      Atrial fibrillation will be the primary target while data on pacemaker driven rhythms and
      other arrhythmia types will also be collected to explore overall performance.
observational model: Case-Only
time perspective: Prospective
measure: Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2
time frame: The PICC insertion procedure is 60-90 mins in duration
description: Tip positioning is determined at bedside by the software via the Green Diamond Indicator (GDI+) and confirmed by CXR. PICC tip placement will be considered successful if it is determined to be in the lower 1/3 of the SVC or in the CAJ by an independent, blinded radiologist judging position retrospectively against pre-specified anatomical criteria.
measure: Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2 in the absence of a GDI
time frame: The PICC insertion procedure is 60-90 mins in duration
description: It is expected there will be some cases where the MODUS II software may fail to present a Green Diamond Indicator (GDI-). In the absence of a GDI, tip positioning is determined at bedside using magnetic tracking and external measurement per hospital protocol, with CXR required for tip confirmation. PICC tip placement will be considered successful if it is determined to be in the lower 1/3 of the SVC or in the CAJ by an independent, blinded radiologist judging position retrospectively against pre-specified anatomical criteria.
measure: Percent agreement between the site readings of the CXR (standard of care) versus those completed by an independent, blinded radiologist
time frame: The PICC insertion procedure is 60-90 mins in duration
description: An independent, blinded radiologist will judge PICC tip position retrospectively against pre-specified anatomical criteria compared with findings of the SLM2.
arm group label: PICC Placement with Study Device
description: PICC Placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software
intervention type: Procedure
intervention name: PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software
description: The SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) is an FDA-cleared fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology, indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients without any alterations of cardiac rhythms that change the normal presentation of the P-wave. A software package, MODUS II, has been developed to accurately analyze the entire ECG complex and identify the correct placement of the PICC tip based on a patient's individual ECG, in the absence of an easily identifiable P-wave. This software system is designed to provide visual and/or audio cues to notify the PICC placer of the location of the PICC tip relative to the cavoatrial junction (CAJ) of the patient.
arm group label: PICC Placement with Study Device
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Rushil Sankpal
role: Study Director
affiliation: Becton Dickinson
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: United States
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Tachycardia
mesh term: Atrial Flutter
mesh term: Bundle-Branch Block
mesh term: Atrioventricular Block
mesh term: Ventricular Premature Complexes
mesh term: Atrial Premature Complexes
sharing ipd: No