Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-24 @ 11:46 PM
NCT ID:
NCT06792851
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.
Study:
NCT06792851
Study Brief:
Protocol Section:
NCT06792851