A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Caption Health, Inc.
Study ID
NCT05992324
Status
Recruiting
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Conditions

  • Shortness of Breath

Eligibility Criteria

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

Interventions

  • Caption LungAI — DEVICE
    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 Details

The purpose of this study is to assess the efficacy of Caption LungAI.

Key Dates

Start date
Jul 17, 2023
Status verified
Nov 2024
Primary completion
Dec 31, 2024
Completion
Mar 1, 2025

Study Design

Enrollment
220 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients presenting with clinical suspicion of B-Lines
    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.

Primary Outcome Measure

Diagnostic Image Quality (Trained Healthcare Professional) [ Time Frame: Up to 24 weeks from completion of the study. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510
Ryan Denkewicz
[email protected]
Chris Moore, MD
Northwestern UniversityChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
The Moses H. Cone Memorial HospitalGreensboroNorth Carolina27401-

Find similar trials in New Haven, CT

By research site
Yale New Haven Hospital· New Haven, CTNorthwestern University· Chicago, ILRush University Medical Center· Chicago, ILThe Moses H. Cone Memorial Hospital· Greensboro, NC

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