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Comparing an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System

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ClinicalTrials.gov Identifier: NCT03764111
Recruitment Status : Completed
First Posted : December 4, 2018
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment
Ultrasonography Device: Large Mobile Ultrasound System Device: Handheld Ultrasound Machine

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Image Quality Comparison Between an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System
Actual Study Start Date : October 23, 2018
Actual Primary Completion Date : November 11, 2020
Actual Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
large mobile ultrasound system
the ultrasound transducer is based on piezoelectric technology.
Device: Large Mobile Ultrasound System
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.
Other Name: Sonosite - M turbo

handheld ultrasound machine
The handheld device utilizes Capacitive micro-machined ultrasound transducers (CMUTs) instead of piezoelectric technology
Device: Handheld Ultrasound Machine
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.
Other Name: Butterfly iQ device




Primary Outcome Measures :
  1. Ultrasound image quality-resolution [ Time Frame: Prior to start of active labor or before elective cesarean delivery ]
    Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.

  2. Ultrasound image quality-details [ Time Frame: Prior to start of active labor or before elective cesarean delivery ]
    Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.

  3. Ultrasound image quality-total image quality [ Time Frame: Prior to start of active labor or before elective cesarean delivery ]
    Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients between the ages of 18 and 45 presenting for cesarean delivery requesting a transverse abdominis block, epidural, or in need of an obstetric US.
Criteria

Inclusion Criteria:

  • Patients needing a routine obstetric scan or requesting a transverse abdominis block, labor epidural or spinal for cesarean delivery.

Exclusion Criteria:

  • Body Mass Index (BMI) > 45

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764111


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Antonio Gonzalez, MD Yale University
Publications:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03764111    
Other Study ID Numbers: 2000024151
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes