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

Ultrasound Image Quality Comparison Between an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03764111
Enrollment
60
Registered
2018-12-04
Start date
2018-10-23
Completion date
2020-12-30
Last updated
2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasonography

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.

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.

Interventions

DEVICELarge 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.

DEVICEHandheld 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.

Sponsors

Yale University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ultrasound image quality-resolutionPrior to start of active labor or before elective cesarean deliveryImages will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.
Ultrasound image quality-detailsPrior to start of active labor or before elective cesarean deliveryImages will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.
Ultrasound image quality-total image qualityPrior to start of active labor or before elective cesarean deliveryImages will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026