A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Caption Health, Inc.
- Enrollment
- 220
- Locations
- 8
- Primary Endpoint
- B-Lines Detection
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
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
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
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
Secondary Outcomes
- Sub-group Analyses(Up to 24 weeks from completion of the study.)