Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05992324

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Shortness of Breath Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital, New Haven, Connecticut, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic Image Quality (Trained Healthcare Professional)

    Time frame: Up to 24 weeks from completion of the study.

    Evaluate the product's ability to assist the user to capture a LUS image with diagnostic quality. Percentage of zones with diagnostic image quality > 0.80

  2. B-Lines Detection

    Time frame: Up to 24 weeks from completion of the study.

    Evaluate the product's ability to retrospectively detect present B-lines on images acquired by a local expert with no Caption Lung AI assistance. AUROC > 0.80; Sensitivity (Se) > 0.80; Specificity (Sp) > 0.75

  3. B-Line Significance

    Time frame: Up to 24 weeks from completion of the study.

    Evaluate the product's ability to retrospectively detect B-lines of significant severity on images acquired by a local expert with no Caption Lung AI assistance. AUROC > 0.80; Sensitivity (Se) > 0.80; Specificity (Sp) > 0.75

  4. Remote Reader Performance

    Time frame: Up to 24 weeks from completion of the study.

    Evaluate the product's impact on a remote expert reader's ability to interpret LUS images. Difference Between Aided &

    Unaided Groups:

    AUROC > 0.00; Sensitivity (Se) > 0.00; Specificity (Sp) > 0.00

Secondary outcomes

  1. Sub-group Analyses

    Time frame: Up to 24 weeks from completion of the study.

    The following sub-group analyses will be performed for the primary endpoints: age (< 65, ≥ 65), BMI group (< 25, 25 ≤ BMI < 30, ≥ 30), gender (Male / Female), site location, trained HCP, and zone of the image (1 - 8).

Study contacts

Contact information is provided by the study sponsor or research team.

Angeline Trinidad

CONTACT

[email protected]

619-322-0727

Sponsors and collaborators

Lead sponsor

Caption Health, Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 15, 2023
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.