A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy of Caption LungAI.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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-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
- 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
- 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
Secondary Outcome Measures
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients over the age of 18
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale New Haven Hospital | New Haven | Connecticut | United States | 06510 |
| 2 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 3 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 4 | The Moses H. Cone Memorial Hospital | Greensboro | North Carolina | United States | 27401 |
Sponsors and Collaborators
- Caption Health, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LungPivotal