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

Not Applicable

Recruiting

• Conditions: Shortness of Breath
• Interventions: Device: Caption LungAI

• Registration Number: NCT05992324
• Lead Sponsor: Caption Health, Inc.

Brief Summary

The purpose of this study is to assess the efficacy of 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 Timeline

• Study Start: 2023-07-17
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients presenting with clinical suspicion of B-Lines	Caption LungAI	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 Measures

Name	Time	Method
B-Lines Detection	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
Remote Reader Performance	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
Diagnostic Image Quality (Trained Healthcare Professional)	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
B-Line Significance	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

Secondary Outcome Measures

Name	Time	Method
Sub-group Analyses	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).

Trial Locations

Locations (4)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

The Moses H. Cone Memorial Hospital; 🇺🇸 Greensboro, North Carolina, United States