Cardiac DiseaseNCT04203251
Evaluation of TTE Utilization in Medical Surgery Step-Down Unit
An observational study of Cardiac Disease, run by Caption Health, Inc. at 1 site in United States.
Trial summary
This is a non-randomized, un-blinded study to evaluate Caption Health guidance software in patients in the medical surgery step-down unit. Patients will be scanned by a trained hospitalist and up to 4 standard views will be obtained per participant: PLAX, PSAX-PM, AP4 and SubC4. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Caption Health Guidance Technology
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2020to May 2020
- Phase
- Observational
- 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 99 years
- All sexes
- Adult, Older adult
Study population: Patients in the medical surgery step down unit at UCSF.
Who may be able to join
- Patients ≥18 years old
- Patients in the medical surgery step-down clinical setting
- Patients who consent to participating in the study
Who cannot join
- ● Patients with emergent or urgent episodes of injury and illness that can lead to death or disability without rapid intervention
- Unable to lie flat for study
- Patients experiencing a known or suspected acute cardiac event at the time of evaluation
- Patients with severe chest wall abnormalities
- Patients who have undergone pneumonectomy
- Patients with recent abdominal surgery
Show all 9Show fewer
- Patients unwilling or unable to give written informed consent
- Principal Investigator determination to exclude the subject from participation
- Investigators also have the right to withdraw patient from the study in the event of illness, adverse events, or other reasons concerning the health or well-being of the patient, or in the case of non-compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
Trevor Jensen, MD, 415-476-7472, trevor.jensen@ucsf.edu
About this study
Official title: Evaluation of TTE Utilization in Medical Surgery Step-Down Unit: Use of AI Assisted Point-of-Care Echo With Guidance Technology
This is a non-randomized, un-blinded study to evaluate Caption Health guidance software in patients in the medical surgery step-down unit. Patients will be scanned by a trained hospitalist and up to 4 standard views will be obtained per participant: PLAX, PSAX-PM, AP4 and SubC4. Observations will be made regarding human factors and performance of the device.
- Conditions
- Cardiac Disease
- Being tested
- Caption Health Guidance Technology
- Keywords
- Artificial Intelligence, Cardiac Monitoring
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caption Health Guidance TechnologyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time to acquire images
Assess the time to acquire cardiac ultrasound images with and without Caption AI Gudiance
Measured: Up to 3 months
Percentage of attempted studies with clinically useful images
Compare the percentage of clinically useful versus not useful images
Measured: Up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study startMar 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caption Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203251
- Sponsor's protocol ID
- CHUCSF01
- Status last verified
- Dec 2019
- First submitted
- 5 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TTE Utilization in Medical Surgery Step-Down Unit: Use of AI Assisted Point-of-Care Echo With Guidance Technology
- ClinicalTrials.gov ID
- NCT04203251
- Acronym / sponsor ID
- CHUCSF01
- Conditions
- Cardiac Disease
- Keywords
- Artificial Intelligence, Cardiac Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Caption Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 18 Dec 2019 (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 non-randomized, un-blinded study to evaluate Caption Health guidance software in patients in the medical surgery step-down unit. Patients will be scanned by a trained hospitalist and up to 4 standard views will be obtained per participant: PLAX, PSAX-PM, AP4 and SubC4. Observations will be made regarding human factors and performance of the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients in the medical surgery step down unit at UCSF.
Key inclusion criteria (3 listed)
- Patients ≥18 years old
- Patients in the medical surgery step-down clinical setting
- Patients who consent to participating in the study
Key exclusion criteria (9 listed)
- ● Patients with emergent or urgent episodes of injury and illness that can lead to death or disability without rapid intervention
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 |
|---|---|---|
| Caption Health Guidance Technology | Device | – |
Primary outcome
Mean time to acquire images
Time frame: Up to 3 months
Assess the time to acquire cardiac ultrasound images with and without Caption AI Gudiance
Percentage of attempted studies with clinically useful images
Time frame: Up to 3 Months
Compare the percentage of clinically useful versus not useful images
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Caption Health, 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 3 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: status not confirmed, as of the sponsor's last update on 18 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jade Andora, BS (831-521-3821, jade@captionhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean time to acquire images (time frame: Up to 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 18 Dec 2019.