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
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2018
CompletedFirst Submitted
Initial submission to the registry
December 3, 2018
CompletedFirst Posted
Study publicly available on registry
December 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJuly 22, 2021
July 1, 2021
2.1 years
December 3, 2018
July 15, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Ultrasound image quality-resolution
Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.
Prior to start of active labor or before elective cesarean delivery
Ultrasound image quality-details
Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.
Prior to start of active labor or before elective cesarean delivery
Ultrasound image quality-total image quality
Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.
Prior to start of active labor or before elective cesarean delivery
Study Arms (2)
large mobile ultrasound system
the ultrasound transducer is based on piezoelectric technology.
handheld ultrasound machine
The handheld device utilizes Capacitive micro-machined ultrasound transducers (CMUTs) instead of piezoelectric technology
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- Patients needing a routine obstetric scan or requesting a transverse abdominis block, labor epidural or spinal for cesarean delivery.
You may not qualify if:
- Body Mass Index (BMI) \> 45
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale University
New Haven, Connecticut, 06510, United States
Related Publications (1)
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: 21860542BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Gonzalez, MD
Yale University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2018
First Posted
December 4, 2018
Study Start
October 23, 2018
Primary Completion
November 11, 2020
Study Completion
December 30, 2020
Last Updated
July 22, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share