Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449872
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-05-20
Brief Title:
OB-GYN Clinical Validation Study
Sponsor:
EchoNous Inc
Organization:
EchoNous Inc
Study Overview
Official Title:
ECHO-007 OB-GYN Clinical Validation Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 viewsstructures 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 viewsstructures on the Mindray M9 Ultrasound System then switched over to the Kosmos Diagnostic Ultrasound System to capture the same viewsstructures Once all viewsstructures 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
The following viewsstructures 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 viewsstructures on the Mindray M9 Ultrasound System then switched over to the Kosmos Diagnostic Ultrasound System to capture the same viewsstructures Once all viewsstructures 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None