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Lung DiseaseNCT07046234

Point of Care Lung Ultrasound Examination in Patients With Shortness of Breath

A study testing Lung ultrasound in people with Lung Disease and Lung Ultrasound, run by GE Healthcare at 3 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This is a prospective, non-randomized clinical validation research study. Subjects will consent and have two ultrasounds as part of the study. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Lung Disease, Lung Ultrasound
What is being tested?
Lung ultrasound
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
3 sitesUnited States
Study dates
19 Aug 2025to Dec 2025
Phase
Interventional
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 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients over the age of 22; AND
  • 2. Patients with known lung pathology or patients with no known lung pathology in the hospital or presenting to the hospital or outpatient setting with shortness of breath.

Who cannot join

  • 1. Patients in extremis and/or patients in whom a lung ultrasound would not normally be performed;
  • 2. Patients who are unable to consent;
  • 3. Patients who are prisoners; AND
  • 4. Patients who do not speak English fluently.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612-3833

  • Northwestern University

    Evanston, Illinois, 60208

  • Yale University School of Medicine

    New Haven, Connecticut, 06511

Other trials in United States

About this study

This is a prospective, non-randomized clinical validation research study. Subjects will consent and have two ultrasounds as part of the study.

Read the detailed description

This study is to collect data to validate the performance of Caption Lung AI in enabling trained healthcare professionals to perform LUS to obtain diagnostic-quality Lung Ultrasound Studies.

Being tested
Lung ultrasound
Keywords
Lung Ultrasound, Artificial Intelligence
Medical subject headings
Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lung ultrasoundDevice

    Also called SaMD

    Lung ultrasound software.

Study groups in NCT07046234
Study groupRoleWhat they receive
Cohort 1 -Device 1ExperimentalCohort 1 will utilize the Vscan Air CL (curvilinear and linear probes) and SL (sector probe) handheld ultrasound to perform an 8-zone lung ultrasound (LUS) exam. The Trained HCP will be required to capture at least 2 clips per zone using an ultrasound with Caption AI before moving onto the next zone. The scanner can capture multiple clips per zone, via-auto-capture or Save Best Clip (Study Exam). The Expert LUS user will use the same ultrasound system but without Caption Lung AI (Control Exam).
Receives: Device: Lung ultrasound
Cohort 2 -Device 2ExperimentalCohort 2 will utilize the Venue GO ultrasound system to perform a 12-zone lung ultrasound (LUS) exam. All Qualified users using Caption Lung AI will be required to capture at least 2 clips per zone before moving onto the next zone. The scanner can capture multiple clips per zone, via-auto-capture or Save Best Clip (Study Exam). The Qualified user will use the same ultrasound system but without Caption Lung AI (Control Exam).
Receives: Device: Lung ultrasound
Cohort 0 - Vscan (no AI)Active comparatorCohort 0 will utilize the Vscan Air CL (curvilinear and linear probes) and SL (sector probe) handheld ultrasound to perform the following lung ultrasound (LUS) exams.: Each patient will undergo 2 8-zone lung examinations which will be a combination of the enrollment distribution listed below equating to up to 30 subjects with 2 scans per subject (60 scans).
Receives: Device: Lung ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort 1: % of patient studies composed of images acquired by the THCPs with sufficient quality to make a clinical assessment

    The primary endpoint will be based on the majority assessment of the independent expert readers qualitatively assessment of the LUS exam (study level) as being of diagnostic quality.

    Measured: 7 months

  2. Cohort 2: % of patient studies composed of images acquired by the Qualified user to make a clinical assessment

    The primary endpoint will be based on the majority assessment of the independent expert readers qualitatively assessment of the LUS exam (study level) as being of diagnostic quality.

    Measured: 7 months

Secondary outcomes (8)

  1. Cohort 1:

    Sub-group analyses will be performed on the diagnostic image quality performance, with descriptive statistics reported based on age (< 65, ≥ 65), BMI group (< 25, 25 ≤ BMI < 30, ≥ 30), gender (Male / Female), site location, THCP, and zone of the image (1 - 8). The statistical analysis procedure and all applicable performance metrics that were used on the whole sample (i.e., the Primary Outcome Measures) will be repeated for each sub-group level. This will be conducted to ensure that there is no inherent bias where a specific sub-group level has a greater impact on the overall whole-sample performance compared to other levels.

    Measured: 7 months

  2. Cohort 2:

    Sub-group analyses will be performed on the diagnostic image quality performance, with descriptive statistics reported based on age (< 65, ≥ 65), BMI group (< 25, 25 ≤ BMI < 30, ≥ 30), gender (Male / Female), site location, THCP, and zone of the image (1 -12). The statistical analysis procedure and all applicable performance metrics that were used on the whole sample (i.e., the Primary Outcome Measures) will be repeated for each sub-group level. This will be conducted to ensure that there is no inherent bias where a specific sub-group level has a greater impact on the overall whole-sample performance compared to other levels.

    Measured: 7 months

  3. Cohort 1:

    Task-based comparison of the study and control exams:

    • Aided non-experts (i.e., THCP) and unaided experts (i.e., Expert LUS user) clips will be reviewed by expert readers for "normal" and "abnormal" ultrasound assessment at the zone level (B-lines, Pleural effusion, Non-aerated Lung / Consolidation, Lung Sliding).

    Measured: 7 months

  4. Cohort 2:

    Task-based comparison of the study and control exams:

    • Aided user and unaided user (i.e., Qualified user) clips will be reviewed by expert readers for "normal" and "abnormal" ultrasound assessment at the zone level (B-lines, Pleural effusion, Non-aerated Lung / Consolidation, Lung Sliding).

    Measured: 7 months

  5. Cohort 1 and 2:

    Recording mode (% of clips acquired with auto-capture rate versus save best clip).

    Measured: 7 months

  6. Cohort 1:

    Acquisition time to complete the LUS exam and for each view (1 - 8).

    Measured: 7 months

  7. Cohort 2:

    Acquisition time to complete the LUS exam and for each view (1 - 12).

    Measured: 7 months

  8. Cohort 1 and 2:

    Inter-rater (physician image-interpretation) variability.

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2025
  2. Study start19 Aug 2025
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07046234
Sponsor's protocol ID
SA-000147
Status last verified
Sep 2025
First submitted
6 Jun 2025
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lung ultrasound in people with Lung Disease and Lung Ultrasound, run by GE Healthcare at 3 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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

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?

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?

Cohort 1: % of patient studies composed of images acquired by the THCPs with sufficient quality to make a clinical assessment (time frame: 7 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?

On the ClinicalTrials.gov record for NCT07046234.

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 3 Oct 2025.

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