NCT05992324

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Caption Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Shortness of Breath

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-17
• Primary completion: 2024-12-31
• Completion: 2025-03-01
• First posted: 2023-08-15
• Last updated: 2024-11-26

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study