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

Shortness of Breath Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992324
• Other study ID #: LungPivotal
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: August 2023
• Source: Caption Health, Inc.
• Contact: Roman Zingarelli
• Phone: 6145786384
• Email: roman[@]captionhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Shortness of Breath

Intervention

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.

Locations

Country	Name	City	State
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	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Caption Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.