ECHO-012 Kosmos Bladder Clinical Validation Study

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.

Study Overview

• Status: Completed
• Conditions: Bladder Disease; Bladder Function; Bladder Dysfunction; Bladder Retention Volume
• Intervention / Treatment: Device: Kosmos Bladder Volume Algorithm

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bladder Volume Measurement; Pre- and post-void bladder volume assessment using Kosmos device by both nurse and sonographer and void volume measurement.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manual Bladder Volume vs. Kosmos Automated Bladder Volume	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.	Post data acquisition (one month)

Collaborators and Investigators

• Sponsor: EchoNous Inc.
• Collaborators: Rainier Clinical Research Center
• Investigators: Principal Investigator: Sheryl Marks, M.D., Rainier Clinical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urinary Retention; Urinary Bladder Diseases
• Other Study ID Numbers: ECHO-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes