ECHO-012 Kosmos Bladder Clinical Validation Study

Not Applicable

Completed

• Conditions: Bladder Disease; Bladder Retention Volume; Bladder Dysfunction; Bladder Function

• Registration Number: NCT06792851
• Lead Sponsor: EchoNous Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-05
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15
• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Read and sign an English consent form, or assent form, in the case of a minor child

• Read and complete an English demographic and general health survey, or have an LAR complete it for them in the case of a minor child

• Give consent for participation, or assent in the case of a minor child

• Able and willing to comply with study requirements

• Follow fluid consumption requirements prior to the study visit

• Those aged 7 years through 89 years, healthy as well as individuals with pelvic region abnormalities (if applicable), including but not limited to:

  i) Bladder cancer ii) Thickened bladder wall iii) Bladder stones iv) Current bladder or urinary tract infection

Exclusion Criteria

• Adults over 89 years old
• Children under the age of 7
• Persons who are pregnant
• Persons who report an empty bladder upon arrival at their scheduled study visit
• Children in foster care, as a foster parent may not legally consent for a foster child
• Those who cannot or refuse to sign their consent or assent (including those with an LAR willing to provide consent)
• Those who cannot provide informed consent or whose LAR cannot provide consent
• Those who cannot speak or read English
• Participants from ECHO-010 Bladder AI Training and Validation Data Collection Study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Manual Bladder Volume vs. Kosmos Automated Bladder Volume	Post data acquisition (one month)	Kosmos Automated Bladder Volume and exam images will be captured using the Kosmos Ultrasound Diagnostic System by a nurse and a sonographer for each participant with both a full and empty bladder. Three independent sonographers will manually measure exam images for bladder length (L), width (W), and height (H). Volume will be calculated using: Bladder Volume = k×L×D×W where k is the correction coefficient. These results from the three sonographers will be averaged. The Pearson correlation coefficient between the average manual bladder volume and the Kosmos calculated pre-void volume will be calculated using the following equation: r=\[∑(x-xbar)(y-ybar)\]/\[∑(x-xbar)\^2 ∑(y-ybar)\^2\] Where x is the manual bladder volume, y is the Kosmos bladder volume, xbar is the mean of the manual bladder volume, and ybar is the mean of the Kosmos bladder volume. A successful outcome would be a correlation coefficient (r) of \>0.90 on bladder exams acquired by both nurses and sonographers.

Trial Locations

Locations (1)

Rainier Clinical Research Center; 🇺🇸 Renton, Washington, United States