Trials / Completed
CompletedNCT06792851
ECHO-012 Kosmos Bladder Clinical Validation Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 146 (actual)
- Sponsor
- EchoNous Inc. · Industry
- Sex
- All
- Age
- 7 Years – 89 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Kosmos Bladder Volume Algorithm | Participants underwent Kosmos bladder volume assessment by both a nurse and an abdominal sonographer pre-void. Participants voided and measured void volume. Participants underwent Kosmos bladder volume assessment by both a nurse and an abdominal sonographer post-void. Kosmos calculated volume measurements were compared to volume measurements calculated using calipers placed by sonographers by hand. |
Timeline
- Start date
- 2024-08-05
- Primary completion
- 2024-08-15
- Completion
- 2024-08-15
- First posted
- 2025-01-27
- Last updated
- 2025-01-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06792851. Inclusion in this directory is not an endorsement.