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| Name | Class |
|---|---|
| Rainier Clinical Research Center | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder Volume Measurement | Experimental | Pre- and post-void bladder volume assessment using Kosmos device by both nurse and sonographer and void volume measurement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kosmos Bladder Volume Algorithm | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post data acquisition (one month) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Sheryl Marks, M.D. | Rainier Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
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| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D052801 | Male Urogenital Diseases |