NCT06449872

OB-GYN Clinical Validation Study

ECHO-007 OB-GYN Clinical Validation Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: EchoNous Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obstetric Complication
• GYN Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-24
• Primary completion: 2023-11-29
• Completion: 2024-04-30
• First posted: 2024-06-10
• Last updated: 2024-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study