ECHO-012 Kosmos Bladder Clinical Validation Study

NCT ID: NCT06792851

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2024-08-15

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.

Conditions

Bladder Disease; Bladder Retention Volume; Bladder Dysfunction; Bladder Function

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Bladder Volume Measurement

Pre- and post-void bladder volume assessment using Kosmos device by both nurse and sonographer and void volume measurement.

Group Type: EXPERIMENTAL

Kosmos Bladder Volume Algorithm

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rainier Clinical Research Center

OTHER

Sponsor Role: collaborator

EchoNous Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheryl Marks, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rainier Clinical Research Center

Locations

Rainier Clinical Research Center

Renton, Washington, United States

Countries

United States

Other Identifiers

ECHO-012

Identifier Type: -

Identifier Source: org_study_id