Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-29 @ 7:44 PM
Study NCT ID:
NCT06792851
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2025-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECHO-012 Kosmos Bladder Clinical Validation Study
Sponsor:
EchoNous Inc.
Organization:
Study Overview
Official Title:
ECHO-012 Kosmos Bladder Clinical Validation Study
Status:
COMPLETED
Status Verified Date:
2025-01
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:
The goal of this clinical trial is to compare the Kosmos Automatic Bladder Volume to the manual annotated bladder volume in participants across gender (male and female), age (children ages 7-17 and adults 18-89), and BMI strata (low to normal and high BMI). The hypothesis it aims to evaluate is: The Pearson correlation coefficient between Kosmos estimated bladder volume and manually annotated bladder volume will yield more than 0.90.
Participants will:
* Have their full bladders scanned and bladder volume calculated using the Kosmos Ultrasound Diagnositic System by both a nurse and sonographer.
* Participants will void and measure their urine volume.
* Participants empty bladders will be scanned and bladder volume calculated using the Kosmos Ultrasound Diagnositic System again by both a nurse and sonographer.
* Three sonographers will manually annotate the pre- and post-void exam images for each patient to calculate the manually annotated bladder volume.
Participants will:
* Have their full bladders scanned and bladder volume calculated using the Kosmos Ultrasound Diagnositic System by both a nurse and sonographer.
* Participants will void and measure their urine volume.
* Participants empty bladders will be scanned and bladder volume calculated using the Kosmos Ultrasound Diagnositic System again by both a nurse and sonographer.
* Three sonographers will manually annotate the pre- and post-void exam images for each patient to calculate the manually annotated bladder volume.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: