Cardiac DisorderNCT06468787
Kosmos Anatomical Object Labeling and View Identification Pivotal Study
A study testing Kosmos Anatomical Object Labeling and View Identification Algorithms in people with Cardiac Disorder and Hepatic Disorder, run by EchoNous Inc. at 1 site in United States.
Trial summary
This is a multi-site, multi-group study that obtained two sets of ultrasound scans from all enrolled participants. Participants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers. Algorithm's performance on the view identification task and the object labeling task is computed. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disorder, Hepatic Disorder, Spleen Disorder
- What is being tested?
- Kosmos Anatomical Object Labeling and View Identification Algorithms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2024to 22 Feb 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons able to:
- Read and sign an English consent form.
- Give consent for participation.
- Able and willing to comply with study requirements.
- Those aged 18 years through 89 years, healthy as well as individuals with pathology, including but not limited to:
- Persons with heart-related conditions such as myocardial or pericardial disease.
- Persons with lung-related conditions such as: asthma, COPD, bronchitis, pulmonary fibrosis, sarcoidosis, pulmonary hypertension, pulmonary hypertension, bronchiectasis, lung cancer, pneumonia, pulmonary edema, pulmonary embolism
- Persons with abdomen-related conditions such as: pancreatitis, gastroesophageal reflux disease, irritable bowel syndrome, colitis, gastroenteritis, ulcers, abdominal aortic aneurysm, splenomegaly, liver disease, kidney disease.
Who cannot join
- Children (minors) under 18 years old
- Adults over 89 years old
- Pregnant individuals
- Those who cannot or refuse to sign their consent
- Those who cannot provide informed consent
- Those who cannot speak or read English
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- Vulnerable populations, i.e., individuals whose willingness to participate in the study could be unduly influenced by the expectation of medical benefits associated with participation
- Individuals with mobility issues that prevent them from having an echo examination
- Individuals with severe chest deformities, or other critical clinical situations, e.g., life critical urgent situations where there is no time for anything else than what is needed for patient care, that prevent them from having an echo examination.
Trial locations and contacts
1 site in 1 country.
United States1 site
REVIVAL research institute, LLC
Sherman, Texas, 75092
About this study
Official title: ECHO-009 Kosmos Anatomical Object Labeling and View Identification Pivotal Study
This is a multi-site, multi-group study that obtained two sets of ultrasound scans from all enrolled participants. Participants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers. Algorithm's performance on the view identification task and the object labeling task is computed.
- Conditions
- Cardiac Disorder, Hepatic Disorder, Spleen Disorder, Kidney Disorder, Pulmonary Disorder, Renal Disorder
- Being tested
- Kosmos Anatomical Object Labeling and View Identification Algorithms
- Medical subject headings
- Heart Diseases, Digestive System Diseases, Splenic Diseases, Kidney Diseases, Lung Diseases, Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kosmos Anatomical Object Labeling and View Identification AlgorithmsDevice
Participants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers. Algorithm's performance on the view identification task and the object labeling task is compared to majority opinion of 5 radiologists.
| Study group | Role | What they receive |
|---|---|---|
| Anatomical Object Labeling and View Identification Comparison | Experimental | Labeling and identification comparative assessment Receives: Device: Kosmos Anatomical Object Labeling and View Identification Algorithms |
What is being measured
The primary outcome is the main question the study is designed to answer.
False discovery rate of the anatomical object labeling function on expert-obtained images
The objective of this study is to compare the average frame-level disagreement of object labeling by majority opinion of five expert reviewers. The frame-level disagreement is defined as False Discovery Rate as in (1) FDR = 1-Precision=FP/(FP+TP) (1) Where TP≡True Positive and FP≡False Positive. A True Positive is counted when the majority opinion of five expert reviewers agrees with the location of predicted labels in the image. A False Positive counted when majority opinion of five expert reviewers disagrees with the location of one or more predicted labels.
False Discovery Rate (FDR) is measured for a particular image frame between predicted objects and the majority opinion of five reviewers. The frame-level FDR threshold for this prospective study is 20%. Therefore, for a successful outcome the frame-level FDR must be less than 20%.
Measured: Post data acquisition (3 months)
False discovery rate of the anatomical view identification function on expert-obtained images
The objective of this study is to compare the average frame-level disagreement of object labeling by majority opinion of five expert reviewers. The frame-level disagreement is defined as False Discovery Rate as in (1) FDR = 1-Precision=FP/(FP+TP) (1) Where TP≡True Positive and FP≡False Positive. A True Positive is counted when the majority opinion of five expert reviewers agrees with the location of predicted labels in the image. A False Positive counted when majority opinion of five expert reviewers disagrees with the location of one or more predicted labels.
False Discovery Rate (FDR) is measured for a particular image frame between predicted objects and the majority opinion of five reviewers. The frame-level FDR threshold for this prospective study is 20%. Therefore, for a successful outcome the frame-level FDR must be less than 20%.
Measured: Post data acquisition (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start7 Feb 2024
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DisorderStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- EchoNous Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asad Karim, MD, Principal investigator, Revival Research Institute LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468787
- Sponsor's protocol ID
- ECHO-009
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECHO-009 Kosmos Anatomical Object Labeling and View Identification Pivotal Study
- ClinicalTrials.gov ID
- NCT06468787
- Acronym / sponsor ID
- ECHO-009
- Conditions
- Cardiac Disorder, Hepatic Disorder, Spleen Disorder, Kidney Disorder, Pulmonary Disorder, Renal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- EchoNous Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 21 Jun 2024 (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.
This is a multi-site, multi-group study that obtained two sets of ultrasound scans from all enrolled participants. Participants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers. Algorithm's performance on the view identification task and the object labeling task is computed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anatomical Object Labeling and View Identification Comparison | Experimental | Device: Kosmos Anatomical Object Labeling and View Identification AlgorithmsLabeling and identification comparative assessment |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Persons able to:
- Read and sign an English consent form.
- Give consent for participation.
- Able and willing to comply with study requirements.
- Those aged 18 years through 89 years, healthy as well as individuals with pathology, including but not limited to:
Key exclusion criteria (9 listed)
- Children (minors) under 18 years old
- Adults over 89 years old
- Pregnant individuals
- Those who cannot or refuse to sign their consent
- Those who cannot provide informed consent
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 Anatomical Object Labeling and View Identification AlgorithmsParticipants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers. Algorithm's performance on the view identification task and the object labeling task is compared to majority opinion of 5 radiologists. | Device | Anatomical Object Labeling and View Identification Comparison |
Primary outcome
False discovery rate of the anatomical object labeling function on expert-obtained images
Time frame: Post data acquisition (3 months)
The objective of this study is to compare the average frame-level disagreement of object labeling by majority opinion of five expert reviewers. The frame-level disagreement is defined as False Discovery Rate as in (1) FDR = 1-Precision=FP/(FP+TP) (1) Where TP≡True Positive and FP≡False Positive. A True Positive is counted when the majority opinion of five expert reviewers agrees with the location of predicted labels in the image. A False Positive counted when majority opinion of five expert reviewers disagrees with the location of one or more predicted labels. False Discovery Rate (FDR) is measured for a particular image frame between predicted objects and the majority opinion of five reviewers. The frame-level FDR threshold for this prospective study is 20%. Therefore, for a successful outcome the frame-level FDR must be less than 20%.
False discovery rate of the anatomical view identification function on expert-obtained images
Time frame: Post data acquisition (3 months)
The objective of this study is to compare the average frame-level disagreement of object labeling by majority opinion of five expert reviewers. The frame-level disagreement is defined as False Discovery Rate as in (1) FDR = 1-Precision=FP/(FP+TP) (1) Where TP≡True Positive and FP≡False Positive. A True Positive is counted when the majority opinion of five expert reviewers agrees with the location of predicted labels in the image. A False Positive counted when majority opinion of five expert reviewers disagrees with the location of one or more predicted labels. False Discovery Rate (FDR) is measured for a particular image frame between predicted objects and the majority opinion of five reviewers. The frame-level FDR threshold for this prospective study is 20%. Therefore, for a successful outcome the frame-level FDR must be less than 20%.
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 21 Jun 2024.
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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.
Asad Karim, MD principal investigator
Revival Research Institute LLC
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 Anatomical Object Labeling and View Identification Algorithms in people with Cardiac Disorder and Hepatic Disorder, 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 8 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 21 Jun 2024. 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?
False discovery rate of the anatomical object labeling function on expert-obtained images (time frame: Post data acquisition (3 months)). The study lists 2 primary outcomes in all. 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 21 Jun 2024.