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

Caption Health

Status: Enrolling

Conditions: Shortness of Breath

Treatments: Device: Caption LungAI

Study type: Interventional

Funder types: Industry

Identifiers

NCT05992324

LungPivotal

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

220 participants in 1 patient group

Patients presenting with clinical suspicion of B-Lines

Experimental group

Description:

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.

Treatment:

Device: Caption LungAI