Clinical trial NCT06792851: ECHO-012 Kosmos Bladder Clinical Validation Study
Official title: ECHO-012 Kosmos Bladder Clinical Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Disease
Bladder Retention Volume
Bladder Dysfunction
Bladder Function
Lead sponsor: EchoNous Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rainier Clinical Research Center
First posted: 2025-01-27
Enrollment: 146
Sex: ALL
Minimum age (years): 7
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Manual Bladder Volume vs. Kosmos Automated Bladder Volume
timeFrame: Post data acquisition (one month)
Secondary outcomes:
Other outcomes:
Locations:
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Rainier Clinical Research Center
name: Sheryl Marks, M.D.
role: PRINCIPAL_INVESTIGATOR
References: