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

Last updated: November 22, 2024
Sponsor: Caption Health, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Caption LungAI

Clinical Study ID

NCT05992324
LungPivotal
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over the age of 18

  • Patients presenting to the hospital or outpatient setting with shortness of breathand suspected B-lines.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: Caption LungAI
Phase:
Study Start date:
July 17, 2023
Estimated Completion Date:
March 01, 2025

Study 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.

Connect with a study center

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Completed

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Completed

  • The Moses H. Cone Memorial Hospital

    Greensboro, North Carolina 27401
    United States

    Completed

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