OB-GYN Clinical Validation Study

Obstetric Complication Clinical Trial

Official title:

ECHO-007 OB-GYN Clinical Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06449872
• Other study ID #: ECHO-007
• Status: Completed
• Phase: N/A
• Start date: October 24, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2024
• Source: EchoNous Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 30, 2024
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genital Diseases, Female
• GYN Disorders
• Obstetric Complication

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	EchoNous, Inc.	Redmond	Washington

Sponsors (1)

Lead Sponsor	Collaborator
EchoNous Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Ultrasound Image Quality Score	Qualitative image assessment of required views/structures generated with Kosmos Diagnostic Ultrasound System versus a cart-based ultrasound system.	Through study completion, up to 1 month