Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-04-24 @ 5:59 PM
Study NCT ID:
NCT04891705
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2021-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study
Sponsor:
Philips Clinical & Medical Affairs Global
Organization:
Study Overview
Official Title:
Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AI
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: