Clinical trial NCT06449872: OB-GYN Clinical Validation Study
Official title: ECHO-007 OB-GYN Clinical Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Complication
GYN Disorders
Lead sponsor: EchoNous Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-10
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single-site study evaluating obstetrics and gynecology exam imaging quality by expert users.

Detailed description: Six healthcare professionals with training and experience in Obstetrics and Gynecology ultrasound qualitatively assessed the image quality of the Kosmos Diagnostic Ultrasound System compared to the benchmark Mindray M9 Ultrasound System. Five sonographers were required to complete each scanning cohort of at least three gravid and three non-gravid participants. A sixth sonographer was added to the study to accommodate a scheduling conflict and provided additional image quality data outside of the five completed cohorts.

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.

Eligibility criteria: Inclusion Criteria:

1. Persons able to:

   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:

1. Children (minors) under 18 years old.
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.

Primary outcomes:
measure: Average Ultrasound Image Quality Score
timeFrame: Through study completion, up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Redmond
country: United States
facility: EchoNous, Inc.
state: Washington
Study officials:
affiliation: Mercy West Hospital
name: Robert Blankenship, MD
role: PRINCIPAL_INVESTIGATOR
References: