Bladder DiseaseNCT06792851
ECHO-012 Kosmos Bladder Clinical Validation Study
A study testing Kosmos Bladder Volume Algorithm in people with Bladder Disease and Bladder Retention Volume, run by EchoNous Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Disease, Bladder Retention Volume, Bladder Dysfunction
- What is being tested?
- Kosmos Bladder Volume Algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
- Bladder cancer ii) Thickened bladder wall iii) Bladder stones iv) Current bladder or urinary tract infection
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainier Clinical Research Center
Renton, Washington, 98057
About this study
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.
- Being tested
- Kosmos Bladder Volume Algorithm
- Medical subject headings
- Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kosmos Bladder Volume AlgorithmDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Volume Measurement | Experimental | Pre- and post-void bladder volume assessment using Kosmos device by both nurse and sonographer and void volume measurement. Receives: Device: Kosmos Bladder Volume Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post data acquisition (one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start5 Aug 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- EchoNous Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rainier Clinical Research Center
- Responsible party
- Sponsor
- Investigators
- Sheryl Marks, M.D., Principal investigator, Rainier Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792851
- Sponsor's protocol ID
- ECHO-012
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECHO-012 Kosmos Bladder Clinical Validation Study
- ClinicalTrials.gov ID
- NCT06792851
- Acronym / sponsor ID
- ECHO-012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- EchoNous Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rainier Clinical Research Center
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder Volume Measurement | Experimental | Device: Kosmos Bladder Volume AlgorithmPre- and post-void bladder volume assessment using Kosmos device by both nurse and sonographer and void volume measurement. |
Who may qualify
- Ages
- 7 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kosmos Bladder Volume AlgorithmParticipants 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. | Device | Bladder Volume Measurement |
Primary outcome
Manual Bladder Volume vs. Kosmos Automated Bladder Volume
Time frame: Post data acquisition (one month)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl Marks, M.D. principal investigator
Rainier Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kosmos Bladder Volume Algorithm in people with Bladder Disease and Bladder Retention Volume, run by EchoNous Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual Bladder Volume vs. Kosmos Automated Bladder Volume (time frame: Post data acquisition (one month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025; AzTrials last refreshed its copy on 27 Oct 2026.