Recruiting

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

Sponsor:

Caption Health, Inc.

Code:

NCT05992324

Conditions

Shortness of Breath

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Caption LungAI

Study Details

Brief summary:

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

Conditions

Shortness of Breath

Study ID

NCT05992324

Start date

Jul 17, 2023

Status verified date

Nov, 2024

Completion date

Mar 1, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients over the age of 18
Patients presenting to the hospital or outpatient setting with shortness of breath and suspected B-lines.

Exclusion Criteria:

Patients in extremis/in whom a research lung ultrasound would not normally be performed due to other priorities

Study Design

Enrollment

220 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Caption LungAI

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.

Primary outcome measure

Diagnostic Image Quality (Trained Healthcare Professional) [ Time Frame: Up to 24 weeks from completion of the study. ]
B-Lines Detection [ Time Frame: Up to 24 weeks from completion of the study. ]
B-Line Significance [ Time Frame: Up to 24 weeks from completion of the study. ]
Remote Reader Performance [ Time Frame: Up to 24 weeks from completion of the study. ]

Central Contacts and Locations

Central contacts

Angeline Trinidad

619-322-0727 angeline.trinidad@gehealthcare.com

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Ryan Denkewicz

ryan.denkewicz@yale.edu

More Information

Sponsor

Caption Health, Inc.

Last update posted

Nov 26, 2024

Last verified

Nov, 2024

Keywords

Lung Ultrasound
B-Lines
POCUS by non-expert user

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Caption Health, Inc. on 2024-11-26.