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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
GE Healthcare
Study ID
NCT07046234
Status
Enrolling By Invitation

Conditions

  • Lung Disease
  • Lung Ultrasound

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lung ultrasound — DEVICE
    Lung ultrasound software.

Study Details

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

Key Dates

Start date
Aug 19, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Cohort 1 -Device 1
    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).
  • Experimental: Cohort 2 -Device 2
    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).
  • Active Comparator: Cohort 0 - Vscan (no AI)
    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).

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 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06511-
Rush University Medical CenterChicagoIllinois60612-3833-
Northwestern UniversityEvanstonIllinois60208-

Find similar trials in New Haven, CT

By research site
Yale University School of Medicine· New Haven, CTRush University Medical Center· Chicago, ILNorthwestern University· Evanston, IL

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