COVID-19CAPTION AINCT04336774
CAPTION AI to Minimize Risk of COVID Exposure
A study testing Caption AI in people with COVID-19, run by Duke University at 2 sites in United States.
Trial summary
Participants scheduled for for an echocardiogram (echo) and being evaluated for, or is positive for COVID-19 will be asked if they would be willing to have their echo done using a new software program on one of the hand-held ultrasound scanners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Caption AI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2020to 9 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duke patients within the MICU and COVID overflow areas
- transthoracic echocardiogram ordered by their provider
- suspected or positive for COVID-19.
- Patients who consent to participating in the study or Physician discretion that information to be gained is important to the patient
- Patients ≥18 years old
Who cannot join
- Unable to lie flat for study
- Patients unwilling to give consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Health
Durham, North Carolina, 27710
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Use of Caption AI to Perform a Clinically Indicated Transthoracic Echocardiogram in Patients Being Evaluated for or Positive for COVID-19
Participants scheduled for for an echocardiogram (echo) and being evaluated for, or is positive for COVID-19 will be asked if they would be willing to have their echo done using a new software program on one of the hand-held ultrasound scanners.
The new software program guides the investigator, or any other non-sonographer, to take the best possible pictures of the participants heart. The prior version of this software is already being used clinically and is FDA approved. The main reason for using the updated version is that it's faster and better in terms of guiding the user.
Read the detailed description
To enable healthcare professionals that are not proficient in transthoracic echo (TTE) to acquire images in patients being evaluated for or positive for COVID-19. By leveraging the capabilities of the Caption AI which is designed to train novice users on how to acquire TTE, this would minimize the risk of sonographers to be exposed to COVID-19. Additionally, minimizing sonographer interaction with patients being evaluated for or positive for COVID 19 minimizes the risk of sonographers as vectors for transmission to other patients. Lastly, since the Caption AI device will be dedicated to the COVID wards and COVID ICU and not transported to other locations, use of the CAPTION AI device will help to limit viral transmission via the surfaces of the ultrasound machine. These images will be assessed by qualified medical professionals for diagnosis.
- Conditions
- COVID-19
- Being tested
- Caption AI
- Keywords
- Echocardiogram
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caption AIDevice
Software program that guides the investigator or any other non-sonographer to take the best possible pictures of the heart.
| Study group | Role | What they receive |
|---|---|---|
| Echocardiogram patients | Experimental | Patients scheduled to have an echocardiogram (echo) and who are also being evaluated for, or are positive for COVID-19. Receives: Device: Caption AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patient echos that are not interpretable
Images obtained through the point of care AI machine will be uploaded to the cardiology PACS system and read. If the images are felt to be not interpretable, the echo lab will send a sonographer with a regular echo machine to the patient's room to perform the study.
Measured: Up to 1 hour
Percent of patient echos that provide an automated (AI) LVEF (left ventricular ejection fraction)
There need to be enough images taken of sufficient quality to allow for calculation of an automated LVEF by the AI algorithm
Measured: Up to 1 hour
Time to acquire images as measured by time stamps
Measured: up to 1 hour
Secondary outcomes (1)
Percent of agreement between AI calculate LVEF and LVEF read by physician
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study startJul 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion9 Nov 2020 (estimated)
Why it stopped: Technology was approved by FDA before study enrolled subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Caption Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Sreekanth Vemulapallli, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336774
- Sponsor's protocol ID
- pro00105212
- Acronym
- CAPTION AI
- Status last verified
- Aug 2020
- First submitted
- 3 Apr 2020
- Last updated
- 10 Aug 2020
- 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 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Caption AI to Perform a Clinically Indicated Transthoracic Echocardiogram in Patients Being Evaluated for or Positive for COVID-19
- ClinicalTrials.gov ID
- NCT04336774
- Acronym / sponsor ID
- CAPTION AI / pro00105212
- Conditions
- COVID-19
- Keywords
- Echocardiogram
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Technology was approved by FDA before study enrolled subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Caption Health, Inc.
- Study start
- Jul 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 9 Nov 2020 (estimated)
- First posted
- 7 Apr 2020 (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.
Participants scheduled for for an echocardiogram (echo) and being evaluated for, or is positive for COVID-19 will be asked if they would be willing to have their echo done using a new software program on one of the hand-held ultrasound scanners.
The new software program guides the investigator, or any other non-sonographer, to take the best possible pictures of the participants heart. The prior version of this software is already being used clinically and is FDA approved. The main reason for using the updated version is that it's faster and better in terms of guiding the user.
Detailed description
To enable healthcare professionals that are not proficient in transthoracic echo (TTE) to acquire images in patients being evaluated for or positive for COVID-19. By leveraging the capabilities of the Caption AI which is designed to train novice users on how to acquire TTE, this would minimize the risk of sonographers to be exposed to COVID-19. Additionally, minimizing sonographer interaction with patients being evaluated for or positive for COVID 19 minimizes the risk of sonographers as vectors for transmission to other patients. Lastly, since the Caption AI device will be dedicated to the COVID wards and COVID ICU and not transported to other locations, use of the CAPTION AI device will help to limit viral transmission via the surfaces of the ultrasound machine. These images will be assessed by qualified medical professionals for diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echocardiogram patients | Experimental | Device: Caption AIPatients scheduled to have an echocardiogram (echo) and who are also being evaluated for, or are positive for COVID-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Duke patients within the MICU and COVID overflow areas
- transthoracic echocardiogram ordered by their provider
- suspected or positive for COVID-19.
- Patients who consent to participating in the study or Physician discretion that information to be gained is important to the patient
- Patients ≥18 years old
Key exclusion criteria (2 listed)
- Unable to lie flat for study
- Patients unwilling to give 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 |
|---|---|---|
| Caption AISoftware program that guides the investigator or any other non-sonographer to take the best possible pictures of the heart. | Device | Echocardiogram patients |
Primary outcome
Percent of patient echos that are not interpretable
Time frame: Up to 1 hour
Images obtained through the point of care AI machine will be uploaded to the cardiology PACS system and read. If the images are felt to be not interpretable, the echo lab will send a sonographer with a regular echo machine to the patient's room to perform the study.
Percent of patient echos that provide an automated (AI) LVEF (left ventricular ejection fraction)
Time frame: Up to 1 hour
There need to be enough images taken of sufficient quality to allow for calculation of an automated LVEF by the AI algorithm
Time to acquire images as measured by time stamps
Time frame: up to 1 hour
1 secondary outcome
Percent of agreement between AI calculate LVEF and LVEF read by physician
Time frame: Up to 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- 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.
Sreekanth Vemulapallli, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caption AI in people with COVID-19, run by Duke University at 2 sites 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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Percent of patient echos that are not interpretable (time frame: Up to 1 hour). The study lists 3 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 10 Aug 2020.