<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/NCT03764111</url>
  </required_header>
  <id_info>
    <org_study_id>2000024151</org_study_id>
    <nct_id>NCT03764111</nct_id>
  </id_info>
  <brief_title>Comparing an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System</brief_title>
  <official_title>Ultrasound Image Quality Comparison Between an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the quality of images and diagnostic ability of a handheld device under two&#xD;
      thousand dollars against those of a bigger and more expensive ultrasound machine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ultrasound technology is frequently used to obtain information, usually at patients bedside.&#xD;
      The images obtained are used to guide procedure (i.e central line placement, epidural needle&#xD;
      guidance) or to make diagnosis (i.e abnormal placentation, presence of pneumothorax). Given&#xD;
      that the majority of this procedures and diagnosis are made at bedside, the ideal ultrasound&#xD;
      machine should be portable, lightweight, and within an acceptable price range. Our current&#xD;
      ultrasound machine (Sonosite - M turbo) has a price range from 15,000-20,000 dollars, not&#xD;
      including the different probes that are needed to obtain images at different depths in the&#xD;
      human body. Much of the cost is due to the ultrasound transducers, which have been&#xD;
      traditionally based on piezoelectric technology. Such probes work by passing current through&#xD;
      a piezoelectric crystal (typically quartz) that then vibrates rapidly and generates an&#xD;
      ultrasound pulse. Creating crystal arrays is difficult and often requires hand-manufacturing.&#xD;
      Furthermore, this technology is analog and requires downstream analog-to-digital processing&#xD;
      hardware. Together, these characteristics increase device costs and restrict the broader&#xD;
      dissemination of ultrasound technology.&#xD;
&#xD;
      Recently, the Butterfly iQ company created an ultrasound that is portable and at a price of&#xD;
      slightly under two thousand dollars it allows the physician to obtain images for diagnostic&#xD;
      and/or procedural guidance using a single probe. The company was able to significantly&#xD;
      reduced the cost and the need for additional probes by utilizing Capacitive micro-machined&#xD;
      ultrasound transducers (CMUTs). Essentially instead of relying on the use of specific&#xD;
      piezoelectric crystals (current ultrasound technology), they are using a micro-chip&#xD;
      technology to emit the vibrations that would be used to form an image. Butterfly Network has&#xD;
      developed a CMUT imaging device that has been designed to be compliant with all applicable&#xD;
      FDA safety regulations (see section II.C), while enabling increased portability and real-time&#xD;
      smartphone-based image review due to the integrated circuit design. The Butterfly device was&#xD;
      FDA-approved as of October 2017. The proposed study will compare the images acquired by the&#xD;
      Butterfly iQ and our current Sonosite M-turbo US.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2018</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 11, 2020</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>Ultrasound image quality-resolution</measure>
    <time_frame>Prior to start of active labor or before elective cesarean delivery</time_frame>
    <description>Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ultrasound image quality-details</measure>
    <time_frame>Prior to start of active labor or before elective cesarean delivery</time_frame>
    <description>Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ultrasound image quality-total image quality</measure>
    <time_frame>Prior to start of active labor or before elective cesarean delivery</time_frame>
    <description>Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Ultrasonography</condition>
  <arm_group>
    <arm_group_label>large mobile ultrasound system</arm_group_label>
    <description>the ultrasound transducer is based on piezoelectric technology.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>handheld ultrasound machine</arm_group_label>
    <description>The handheld device utilizes Capacitive micro-machined ultrasound transducers (CMUTs) instead of piezoelectric technology</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Large Mobile Ultrasound System</intervention_name>
    <description>30 spine images, 15 Transverse abdominis muscle and 30 Obstetric images (i.e placenta, uterine blood flow, etc) images will be obtained using the large mobile ultrasound system.</description>
    <arm_group_label>large mobile ultrasound system</arm_group_label>
    <other_name>Sonosite - M turbo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Handheld Ultrasound Machine</intervention_name>
    <description>30 spine images, 15 Transverse abdominis muscle and 30 Obstetric images (i.e placenta, uterine blood flow, etc) images will be obtained using the handheld device.</description>
    <arm_group_label>handheld ultrasound machine</arm_group_label>
    <other_name>Butterfly iQ device</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients between the ages of 18 and 45 presenting for cesarean delivery requesting a&#xD;
        transverse abdominis block, epidural, or in need of an obstetric US.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients needing a routine obstetric scan or requesting a transverse abdominis block,&#xD;
             labor epidural or spinal for cesarean delivery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 45&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Gonzalez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Khuri-Yakub BT, Oralkan O. Capacitive micromachined ultrasonic transducers for medical imaging and therapy. J Micromech Microeng. 2011 May;21(5):54004-54014. doi: 10.1088/0960-1317/21/5/054004.</citation>
    <PMID>21860542</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>July 15, 2021</last_update_submitted>
  <last_update_submitted_qc>July 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03764111
org study id: 2000024151
nct id: NCT03764111
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To assess the quality of images and diagnostic ability of a handheld device under two
      thousand dollars against those of a bigger and more expensive ultrasound machine.
Ultrasound technology is frequently used to obtain information, usually at patients bedside.
      The images obtained are used to guide procedure (i.e central line placement, epidural needle
      guidance) or to make diagnosis (i.e abnormal placentation, presence of pneumothorax). Given
      that the majority of this procedures and diagnosis are made at bedside, the ideal ultrasound
      machine should be portable, lightweight, and within an acceptable price range. Our current
      ultrasound machine (Sonosite - M turbo) has a price range from 15,000-20,000 dollars, not
      including the different probes that are needed to obtain images at different depths in the
      human body. Much of the cost is due to the ultrasound transducers, which have been
      traditionally based on piezoelectric technology. Such probes work by passing current through
      a piezoelectric crystal (typically quartz) that then vibrates rapidly and generates an
      ultrasound pulse. Creating crystal arrays is difficult and often requires hand-manufacturing.
      Furthermore, this technology is analog and requires downstream analog-to-digital processing
      hardware. Together, these characteristics increase device costs and restrict the broader
      dissemination of ultrasound technology.

      Recently, the Butterfly iQ company created an ultrasound that is portable and at a price of
      slightly under two thousand dollars it allows the physician to obtain images for diagnostic
      and/or procedural guidance using a single probe. The company was able to significantly
      reduced the cost and the need for additional probes by utilizing Capacitive micro-machined
      ultrasound transducers (CMUTs). Essentially instead of relying on the use of specific
      piezoelectric crystals (current ultrasound technology), they are using a micro-chip
      technology to emit the vibrations that would be used to form an image. Butterfly Network has
      developed a CMUT imaging device that has been designed to be compliant with all applicable
      FDA safety regulations (see section II.C), while enabling increased portability and real-time
      smartphone-based image review due to the integrated circuit design. The Butterfly device was
      FDA-approved as of October 2017. The proposed study will compare the images acquired by the
      Butterfly iQ and our current Sonosite M-turbo US.
observational model: Cohort
time perspective: Prospective
measure: Ultrasound image quality-resolution
time frame: Prior to start of active labor or before elective cesarean delivery
description: Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.
measure: Ultrasound image quality-details
time frame: Prior to start of active labor or before elective cesarean delivery
description: Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.
measure: Ultrasound image quality-total image quality
time frame: Prior to start of active labor or before elective cesarean delivery
description: Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.
arm group label: large mobile ultrasound system
description: the ultrasound transducer is based on piezoelectric technology.
arm group label: handheld ultrasound machine
description: The handheld device utilizes Capacitive micro-machined ultrasound transducers (CMUTs) instead of piezoelectric technology
intervention type: Device
intervention name: Large Mobile Ultrasound System
description: 30 spine images, 15 Transverse abdominis muscle and 30 Obstetric images (i.e placenta, uterine blood flow, etc) images will be obtained using the large mobile ultrasound system.
arm group label: large mobile ultrasound system
other name: Sonosite - M turbo
intervention type: Device
intervention name: Handheld Ultrasound Machine
description: 30 spine images, 15 Transverse abdominis muscle and 30 Obstetric images (i.e placenta, uterine blood flow, etc) images will be obtained using the handheld device.
arm group label: handheld ultrasound machine
other name: Butterfly iQ device
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Antonio Gonzalez, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
citation: Khuri-Yakub BT, Oralkan O. Capacitive micromachined ultrasonic transducers for medical imaging and therapy. J Micromech Microeng. 2011 May;21(5):54004-54014. doi: 10.1088/0960-1317/21/5/054004.
PMID: 21860542
responsible party type: Sponsor
sharing ipd: No