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ECHO-012 Kosmos Bladder Clinical Validation Study

NCT06792851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-01-27

No results posted yet for this study

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

  • Bladder Disease
  • Bladder Retention Volume
  • Bladder Dysfunction
  • Bladder Function

Interventions

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.

Sponsors & Collaborators

  • Rainier Clinical Research Center

    collaborator OTHER

  • EchoNous Inc.

    lead INDUSTRY

Principal Investigators

  • Sheryl Marks, M.D. · Rainier Clinical Research Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2024-08-15
Completion
2024-08-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06792851 on ClinicalTrials.gov