Ultrasound ImagingNCT05649826
Automated Ultrasound Cardiac Guidance Tool
An observational study of Ultrasound Imaging, run by UltraSight at 1 site in United States.
Trial summary
This research examines echocardiography images taken from cardiac patients in relation to the guidance tool developed Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Ultrasound Imaging
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 200 subjects will be enrolled in this study, at least 35% females and 35% males.
Who may be able to join
- Males and females, aged 18 years and older
- Subject willing and able to give written informed consent
Who cannot join
- Emergency (non-elective) admission within 24 h prior to participating in the study
- Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF
- Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
- Subjects who currently participate in a clinical trial, involving interventional cardiac devices.
- Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report.
- Subjects with BMI above 40.
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- Subjects experiencing a known or suspected acute cardiac event.
- Subjects with severe chest wall deformity as per previous medical records and physical examination.
- Subjects who have undergone pneumonectomy.
- Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e., situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wayne University
Detroit, Michigan, 48201
Laura Gowland, sonographer, 313-577-1268, lgowland@med.wayne.edu
Robert Ehrman, MD
About this study
Official title: Optimization of an Ultrasound Cardiac Guidance Tool
This research examines echocardiography images taken from cardiac patients in relation to the guidance tool developed
Read the detailed description
The study is an open label, single arm prospective study. This goal of the study is to learn about echocardiography images in relation to the developed guidance tool software in cardiac patients population. Participants will undergo one session of transthoracic echocardiography exam. The ultrasound will be performed by a sonographer for images acquiring purposes
- Conditions
- Ultrasound Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of transthoracic echocardiography media from up to 200 subjects
Several echocardiography views will be acquired from the participants, with in several acoustic windows and views
Measured: up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Feb 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound ImagingStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UltraSight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Ehrman, MD, Principal investigator, Wayne University Emergency medicineNoa Avisar, PhD, Study director, UltraSight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649826
- Sponsor's protocol ID
- 002-30 US
- Status last verified
- May 2024
- First submitted
- 3 Apr 2022
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of an Ultrasound Cardiac Guidance Tool
- ClinicalTrials.gov ID
- NCT05649826
- Acronym / sponsor ID
- 002-30 US
- Conditions
- Ultrasound Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- UltraSightIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 14 Dec 2022 (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 research examines echocardiography images taken from cardiac patients in relation to the guidance tool developed
Detailed description
The study is an open label, single arm prospective study. This goal of the study is to learn about echocardiography images in relation to the developed guidance tool software in cardiac patients population. Participants will undergo one session of transthoracic echocardiography exam. The ultrasound will be performed by a sonographer for images acquiring purposes
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 200 subjects will be enrolled in this study, at least 35% females and 35% males.
Key inclusion criteria (2 listed)
- Males and females, aged 18 years and older
- Subject willing and able to give written informed consent
Key exclusion criteria (10 listed)
- Emergency (non-elective) admission within 24 h prior to participating in the study
- Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF
- Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
- Subjects who currently participate in a clinical trial, involving interventional cardiac devices.
- Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acquisition of transthoracic echocardiography media from up to 200 subjects
Time frame: up to 5 year
Several echocardiography views will be acquired from the participants, with in several acoustic windows and views
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 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.
Robert Ehrman, MD principal investigator
Wayne University Emergency medicine
Noa Avisar, PhD study director
UltraSight
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 Ultrasound Imaging, run by UltraSight 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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Ehrman, MD (313-5771268, rehrman@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquisition of transthoracic echocardiography media from up to 200 subjects (time frame: up to 5 year). 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 May 2024.