Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT04891705
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
Study:
NCT04891705
Study Brief:
Protocol Section:
NCT04891705