ECHO-012 Kosmos Bladder Clinical Validation Study

EchoNous

Status

Completed

Conditions

Bladder Retention Volume

Bladder Function

Bladder Dysfunction

Bladder Disease

Treatments

Device: Kosmos Bladder Volume Algorithm

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06792851

ECHO-012

Details and patient eligibility

About

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.

Enrollment

146 patients

Sex

All

Ages

7 to 89 years old

Volunteers

Accepts Healthy Volunteers

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