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

NCT07046234 | Enrolling By Invitation FDA Device

• 1 other identifier: SA-000147
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Lung Disease; Lung Ultrasound

Keywords

Lung Ultrasound; Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

• 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.

  7 months

• 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.

  7 months

Secondary Outcomes (8)

• Cohort 1:

  7 months

• Cohort 2:

  7 months

• Cohort 1:

  7 months

• Cohort 2:

  7 months

• Cohort 1 and 2:

  7 months

Study Arms (3)

Cohort 1 -Device 1

EXPERIMENTAL

Cohort 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).

Device: Lung ultrasound

Cohort 2 -Device 2

EXPERIMENTAL

Cohort 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).

Device: Lung ultrasound

Cohort 0 - Vscan (no AI)

ACTIVE COMPARATOR

Cohort 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).

Device: Lung ultrasound

Interventions

Lung ultrasound DEVICE

Lung ultrasound software.

Also known as: SaMD

Cohort 0 - Vscan (no AI); Cohort 1 -Device 1; Cohort 2 -Device 2

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients over the age of 22; AND
• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• GE Healthcare: lead
• Northwestern University: collaborator
• Rush University Medical Center: collaborator
• Yale University: collaborator

Study Sites (3)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612-3833, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: July 1, 2025
• Study Start: August 19, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)