Shortness of BreathNCT05992324
A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
A study testing Caption LungAI in people with Shortness of Breath, run by Caption Health, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy of Caption LungAI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shortness of Breath
- What is being tested?
- Caption LungAI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Jul 2023to 1 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18
- Patients presenting to the hospital or outpatient setting with shortness of breath and suspected B-lines.
Who cannot join
- Patients in extremis/in whom a research lung ultrasound would not normally be performed due to other priorities
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 1 recruiting
- Completed
Northwestern University
Chicago, Illinois, 60611
- Completed
Rush University Medical Center
Chicago, Illinois, 60612
- Completed
The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06510
Ryan Denkewicz, ryan.denkewicz@yale.edu
Chris Moore, MD
About this study
The purpose of this study is to assess the efficacy of Caption LungAI.
Read the detailed description
After being informed about the study, all patients giving written informed consent will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and one exam conducted by a (non-expert) healthcare provider who is trained on Caption LungAI and will use Caption LungAI to capture images.
- Conditions
- Shortness of Breath
- Being tested
- Caption LungAI
- Keywords
- Lung Ultrasound, B-Lines, POCUS by non-expert user
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caption LungAIDevice
Caption LungAI is a software that is designed to help non-expert healthcare professionals acquire diagnostic quality images on an 8-zone lung protocol for both healthy patients and patients presenting with pathology such as B-Lines.
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting with clinical suspicion of B-Lines | Experimental | Patients will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and will last approximately 5-10 minutes. The second exam will be conducted by a healthcare professional with Caption LungAI and will last approximately 15-20 minutes. Receives: Device: Caption LungAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Image Quality (Trained Healthcare Professional)
Evaluate the product's ability to assist the user to capture a LUS image with diagnostic quality. Percentage of zones with diagnostic image quality > 0.80
Measured: Up to 24 weeks from completion of the study.
B-Lines Detection
Evaluate the product's ability to retrospectively detect present B-lines on images acquired by a local expert with no Caption Lung AI assistance. AUROC > 0.80; Sensitivity (Se) > 0.80; Specificity (Sp) > 0.75
Measured: Up to 24 weeks from completion of the study.
B-Line Significance
Evaluate the product's ability to retrospectively detect B-lines of significant severity on images acquired by a local expert with no Caption Lung AI assistance. AUROC > 0.80; Sensitivity (Se) > 0.80; Specificity (Sp) > 0.75
Measured: Up to 24 weeks from completion of the study.
Remote Reader Performance
Evaluate the product's impact on a remote expert reader's ability to interpret LUS images. Difference Between Aided \&
Unaided Groups:
AUROC > 0.00; Sensitivity (Se) > 0.00; Specificity (Sp) > 0.00
Measured: Up to 24 weeks from completion of the study.
Secondary outcomes (1)
Sub-group Analyses
The following sub-group analyses will be performed for the primary endpoints: age (< 65, ≥ 65), BMI group (< 25, 25 ≤ BMI < 30, ≥ 30), gender (Male / Female), site location, trained HCP, and zone of the image (1 - 8).
Measured: Up to 24 weeks from completion of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start17 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shortness of BreathStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 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
- NCT05992324
- Sponsor's protocol ID
- LungPivotal
- Status last verified
- Nov 2024
- First submitted
- 31 Jul 2023
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Baloescu C, Bailitz J, Cheema B, Agarwala R, Jankowski M, Eke O, Liu R, Nomura J, Stolz L, Gargani L, Alkan E, Wellman T, Parajuli N, Marra A, Thomas Y, Patel D, Schraft E, O'Brien J, Moore CL, Gottlieb M. Artificial Intelligence-Guided Lung Ultrasound by Nonexperts. JAMA Cardiol. 2025 Mar 1;10(3):245-253. doi: 10.1001/jamacardio.2024.4991.
PubMed 39813064
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
- ClinicalTrials.gov ID
- NCT05992324
- Acronym / sponsor ID
- LungPivotal
- Conditions
- Shortness of Breath
- Keywords
- Lung Ultrasound, B-Lines, POCUS by non-expert user
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Caption Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 15 Aug 2023 (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.
The purpose of this study is to assess the efficacy of Caption LungAI.
Detailed description
After being informed about the study, all patients giving written informed consent will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and one exam conducted by a (non-expert) healthcare provider who is trained on Caption LungAI and will use Caption LungAI to capture images.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting with clinical suspicion of B-Lines | Experimental | Device: Caption LungAIPatients will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and will last approximately 5-10 minutes. The second exam will be conducted by a healthcare professional with Caption LungAI and will last approximately 15-20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 18
- Patients presenting to the hospital or outpatient setting with shortness of breath and suspected B-lines.
Key exclusion criteria (1 listed)
- Patients in extremis/in whom a research lung ultrasound would not normally be performed due to other priorities
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 LungAICaption LungAI is a software that is designed to help non-expert healthcare professionals acquire diagnostic quality images on an 8-zone lung protocol for both healthy patients and patients presenting with pathology such as B-Lines. | Device | Patients presenting with clinical suspicion of B-Lines |
Primary outcome
Diagnostic Image Quality (Trained Healthcare Professional)
Time frame: Up to 24 weeks from completion of the study.
Evaluate the product's ability to assist the user to capture a LUS image with diagnostic quality. Percentage of zones with diagnostic image quality > 0.80
B-Lines Detection
Time frame: Up to 24 weeks from completion of the study.
Evaluate the product's ability to retrospectively detect present B-lines on images acquired by a local expert with no Caption Lung AI assistance. AUROC > 0.80; Sensitivity (Se) > 0.80; Specificity (Sp) > 0.75
B-Line Significance
Time frame: Up to 24 weeks from completion of the study.
Evaluate the product's ability to retrospectively detect B-lines of significant severity on images acquired by a local expert with no Caption Lung AI assistance. AUROC > 0.80; Sensitivity (Se) > 0.80; Specificity (Sp) > 0.75
Remote Reader Performance
Time frame: Up to 24 weeks from completion of the study.
Evaluate the product's impact on a remote expert reader's ability to interpret LUS images. Difference Between Aided \& Unaided Groups: AUROC > 0.00; Sensitivity (Se) > 0.00; Specificity (Sp) > 0.00
1 secondary outcome
Sub-group Analyses
Time frame: Up to 24 weeks from completion of the study.
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 26 Nov 2024.
- Derived from this study: PubMed 39813064Baloescu C, Bailitz J, Cheema B, Agarwala R, Jankowski M, Eke O, Liu R, Nomura J, Stolz L, Gargani L, Alkan E, Wellman T, Parajuli N, Marra A, Thomas Y, Patel D, Schraft E, O'Brien J, Moore CL, Gottlieb M. Artificial Intelligence-Guided Lung Ultrasound by Nonexperts. JAMA Cardiol. 2025 Mar 1;10(3):245-253. doi: 10.1001/jamacardio.2024.4991.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caption LungAI in people with Shortness of Breath, run by Caption Health, Inc. at 4 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 1 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Contact Angeline Trinidad (619-322-0727, angeline.trinidad@gehealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Image Quality (Trained Healthcare Professional) (time frame: Up to 24 weeks from completion of the study.). The study lists 4 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 NCT05992324, which also lists 1 linked publication.
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 26 Nov 2024.