An interventional study of Kosmos Bladder Volume Algorithm in Bladder Disease, Bladder Retention Volume and Bladder Dysfunction, sponsored by EchoNous Inc.. Completed at 1 site in United States. Open to participants aged 7 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by EchoNous Inc. · Not applicable, Interventional, and Diagnostic
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:
62 studies on the registry are indexed under Urinary Bladder Diseases; 9 are open to participants now.
This study's enrollment of 146 is above the median of 79 across 42 interventional studies indexed under Urinary Bladder Diseases.
Browse Urinary Bladder Diseases studies →EchoNous Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Post data acquisition (one month)
Ran from Aug 2024 to primary completion in Aug 2024, 0 months.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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EchoNous Inc.