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.

Study Overview

• Status: Recruiting
• Conditions: Shortness of Breath
• Intervention / Treatment: Device: Caption LungAI

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angeline Trinidad; Phone Number: 619-322-0727; Email: angeline.trinidad@gehealthcare.com

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale New Haven Hospital
      • Contact: Ryan Denkewicz; Email: ryan.denkewicz@yale.edu
      • Contact: Chris Moore, MD
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Completed
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Completed
      • Northwestern University
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Completed
      • The Moses H. Cone Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub-group Analyses	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).	Up to 24 weeks from completion of the study.

Collaborators and Investigators

• Sponsor: Caption Health, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Lung Ultrasound; B-Lines; POCUS by non-expert user
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: LungPivotal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No