NCT04891705

Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 554 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is being conducted to collect image data and relevant clinical data from medical records of patients with suspicion of lung consolidation or pleural effusion. The information will be used to test the performance of Artificial Intelligence (AI) in identification of features associated with the above lung conditions.

Detailed description

This is a prospective, observational, multi-center, post-market clinical study. Enrollment will continue (up to a maximum of 500 adult subjects and up to 300 pediatric subjects) until diagnostic LUS exams are acquired for each of the following groups: Approximately 500 Adult subjects targeting: * Approximately 175 exams from patients positive for lung consolidation * Approximately 175 exams from patients positive for pleural effusion * Approximately 150 exams from patients negative for both conditions Approximately 300 pediatric subjects targeting: * Approximately 150 exams from patients positive for lung consolidation * Approximately 150 exams from patients negative for lung consolidation

Conditions

• Pleural Effusion
• Lung Consolidation

Interventions

Type	Name	Description
DEVICE	Lung Ultrasound Scan	Ultrasound scan of subjects in up to 14 lung zones

Timeline

• Start date: 2021-09-11
• Primary completion: 2023-12-14
• Completion: 2023-12-14
• First posted: 2021-05-18
• Last updated: 2023-12-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study