Image, BodyNCT05196776
Diagnostic Accuracy of Handheld vs Traditional Ultrasound
A study testing Portable, handheld point-of-care ultrasound device and Cart-based point-of-care ultrasound device in people with Image, Body, run by Temple University at 1 site in United States.
Trial summary
Patients receiving a point-of-care ultrasound will be randomized into a portable, handheld device or a traditional cart-based ultrasound machine to compare diagnostic capability. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Image, Body
- What is being tested?
- Portable, handheld point-of-care ultrasound device and Cart-based point-of-care ultrasound device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. English and Spanish-speaking patients, who require a gallbladder, cardiac, renal, aorta, or lung ultrasound based on the discretion of the treating physician.
Who cannot join
- All other non-English and non-Spanish speaking patients
- Vulnerable groups
- Patients unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140
About this study
Official title: Diagnostic Accuracy of a Portable, Handheld Point-of-Care Ultrasound Device vs a Traditional Cart-Based Model
Patients receiving a point-of-care ultrasound will be randomized into a portable, handheld device or a traditional cart-based ultrasound machine to compare diagnostic capability.
Read the detailed description
Patients who require a point-of-care ultrasound examination of their kidneys, gallbladder, heart, lung, or aorta will be enrolled. Once enrolled, the patient will be randomized to receive the point-of-care ultrasound using a portable, handheld ultrasound or a traditional cart based model. The ultrasound examinations will be performed by emergency medicine post-graduate year 1-3 residents or an ultrasound fellow and reviewed by the supervising emergency medicine attending physicians credentialed in performing and interpreting point-of-care ultrasound.
Based on the clinical presentation, the provider will perform one of the following ultrasounds: cardiac to assess ejection fraction ( <50%, 30-50%, <30%), lung to assess for presence or absence of B-lines, gallbladder to assess for the presence or absence of gallstones, renal to assess for the presence or absence of hydronephrosis, or aorta to assess for the presence or absence of an aneurysm. The diagnostic accuracy of the portable, handheld and the cart-based model will be assessed using the following as the diagnostic standard: cardiology-interpreted echocardiogram, radiology-interpreted ultrasound or computed tomography, or quality review of the point-of-care ultrasound by 3 ultrasound fellowship trained physicians.
- Conditions
- Image, Body
- Being tested
- Portable, handheld point-of-care ultrasound device, Cart-based point-of-care ultrasound device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable, handheld point-of-care ultrasound deviceDevice
The patient will have an ultrasound performed using a handheld, portable device.
Cart-based point-of-care ultrasound deviceDevice
The patient will have an ultrasound performed using a traditional cart-based model.
| Study group | Role | What they receive |
|---|---|---|
| Portable, Handheld Device | Experimental | Patients will receive a point-of-care ultrasound using a handheld, portable ultrasound device. Receives: Device: Portable, handheld point-of-care ultrasound device |
| Traditional, Cart-based Ultrasound | Active comparator | Patients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine. Receives: Device: Cart-based point-of-care ultrasound device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
The primary outcome will be difference in diagnostic accuracy between the two methods (the percent of diagnostic accuracy of the hand-held and the percent of diagnostic accuracy of the cart-based model).
Measured: 1 day
Secondary outcomes (1)
Image Quality by Expert Review
Using a Likert scale of 1-7 (1 = unable to assess image; 7 = highest quality), ultrasound fellowship-trained providers will assess the image quality of images obtained by each provide in the study.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Oct 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Image, BodyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196776
- Sponsor's protocol ID
- 28766
- Status last verified
- Oct 2023
- First submitted
- 6 Dec 2021
- Last updated
- 1 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of a Portable, Handheld Point-of-Care Ultrasound Device vs a Traditional Cart-Based Model
- ClinicalTrials.gov ID
- NCT05196776
- Acronym / sponsor ID
- 28766
- Conditions
- Image, Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Posted 1 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients receiving a point-of-care ultrasound will be randomized into a portable, handheld device or a traditional cart-based ultrasound machine to compare diagnostic capability.
Detailed description
Patients who require a point-of-care ultrasound examination of their kidneys, gallbladder, heart, lung, or aorta will be enrolled. Once enrolled, the patient will be randomized to receive the point-of-care ultrasound using a portable, handheld ultrasound or a traditional cart based model. The ultrasound examinations will be performed by emergency medicine post-graduate year 1-3 residents or an ultrasound fellow and reviewed by the supervising emergency medicine attending physicians credentialed in performing and interpreting point-of-care ultrasound.
Based on the clinical presentation, the provider will perform one of the following ultrasounds: cardiac to assess ejection fraction ( <50%, 30-50%, <30%), lung to assess for presence or absence of B-lines, gallbladder to assess for the presence or absence of gallstones, renal to assess for the presence or absence of hydronephrosis, or aorta to assess for the presence or absence of an aneurysm. The diagnostic accuracy of the portable, handheld and the cart-based model will be assessed using the following as the diagnostic standard: cardiology-interpreted echocardiogram, radiology-interpreted ultrasound or computed tomography, or quality review of the point-of-care ultrasound by 3 ultrasound fellowship trained physicians.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portable, Handheld Device | Experimental | Device: Portable, handheld point-of-care ultrasound devicePatients will receive a point-of-care ultrasound using a handheld, portable ultrasound device. |
| Traditional, Cart-based Ultrasound | Active comparator | Device: Cart-based point-of-care ultrasound devicePatients will receive a point-of-care ultrasound using a traditional, cart-based ultrasound machine. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. English and Spanish-speaking patients, who require a gallbladder, cardiac, renal, aorta, or lung ultrasound based on the discretion of the treating physician.
Key exclusion criteria (3 listed)
- All other non-English and non-Spanish speaking patients
- Vulnerable groups
- Patients unable to 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 |
|---|---|---|
| Portable, handheld point-of-care ultrasound deviceThe patient will have an ultrasound performed using a handheld, portable device. | Device | Portable, Handheld Device |
| Cart-based point-of-care ultrasound deviceThe patient will have an ultrasound performed using a traditional cart-based model. | Device | Traditional, Cart-based Ultrasound |
Primary outcome
Diagnostic Accuracy
Time frame: 1 day
The primary outcome will be difference in diagnostic accuracy between the two methods (the percent of diagnostic accuracy of the hand-held and the percent of diagnostic accuracy of the cart-based model).
1 secondary outcome
Image Quality by Expert Review
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable, handheld point-of-care ultrasound device and Cart-based point-of-care ultrasound device in people with Image, Body, run by Temple University 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 1 inclusion and 3 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 1 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diagnostic Accuracy (time frame: 1 day). 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 1 Nov 2023.