Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2023-10-24
2024-04-30
Brief Summary
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Detailed Description
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The following views/structures were assessed for image quality:
Gynecology participants:
* Uterus
* Ovaries
* Endometrial cavity
* Cervix
• Obstetrics participants in their 1st trimester:
* General image quality of the fetus
* Ability to visualize the crown rump length
* Visualization of gestational sac
* Visualization of yolk sac if present
• Obstetrics and participants in their 2nd trimester:
* General image quality of the fetal structures
* Visualization of the amniotic fluid
* Visualization of the placenta
* Cardiac motion in 2D and M-mode with heart rate
Obstetrics and participants in their 3rd trimester:
* General image quality of the fetal structures
* Visualization of the amniotic fluid
* Visualization of the placenta
* Visualization of the maternal cervix
* Cardiac motion in 2D and M-mode with heart rate
* 3 vessel umbilical cord in 2D and Color Doppler The sonographers captured all views/structures on the Mindray M9 Ultrasound System, then switched over to the Kosmos Diagnostic Ultrasound System to capture the same views/structures. Once all views/structures were captured on both ultrasound systems, the healthcare professionals reviewed the images in parallel on each system, then provided a comparison score for Kosmos between 1 and 7.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Comparison scanning protocol for OB and GYN clinical applications
Image quality comparative assessment
Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems
Up to 5 healthcare professionals trained and experienced in Obstetrics and Gynaecology ultrasound qualitatively assessed the diagnostic image quality of the Kosmos Diagnostic Ultrasound System against the benchmark Mindray M9 Ultrasound System.
Interventions
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Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems
Up to 5 healthcare professionals trained and experienced in Obstetrics and Gynaecology ultrasound qualitatively assessed the diagnostic image quality of the Kosmos Diagnostic Ultrasound System against the benchmark Mindray M9 Ultrasound System.
Eligibility Criteria
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Inclusion Criteria
1. Read and sign an English consent form.
2. Read and complete an English demographic and general health survey.
3. Give consent for participation.
4. Able and willing to comply with study requirements.
2. Those aged 18 years through 40 years, healthy, particularly in respect to their pregnancy.
3. Pregnant individuals who have received a previous ultrasound exam by their physician.
Exclusion Criteria
2. Adults over 40 years old.
3. Those who cannot or refuse to sign their consent.
4. Those who cannot provide informed consent.
5. Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by the expectation of medical benefits associated with participation.
6. Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by parents, employer or monetary benefit.
7. Pregnant individuals who have not received a previous ultrasound exam by their physician.
8. Individuals who have had a hysterectomy, oophorectomy, and trachelectomy.
18 Years
40 Years
FEMALE
Yes
Sponsors
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EchoNous Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Blankenship, MD
Role: PRINCIPAL_INVESTIGATOR
Mercy West Hospital
Locations
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EchoNous, Inc.
Redmond, Washington, United States
Countries
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Other Identifiers
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ECHO-007
Identifier Type: -
Identifier Source: org_study_id
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