Viewing Study NCT04119960


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Study NCT ID: NCT04119960
Status: COMPLETED
Last Update Posted: 2020-07-28
First Post: 2019-10-07
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Clinical Validation of InferRead Lung CT.AI
Sponsor: Infervision
Organization:

Study Overview

Official Title: Clinical Validation of InferRead Lung CT.AI
Status: COMPLETED
Status Verified Date: 2020-07
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: None
Brief Summary: Lung cancer is the second most common cause of cancer-related death in men and women. Early pulmonary nodule screening is an effective means to prevent lung cancer, which is no less important than the diagnosis and treatment of lung cancer. Early lung cancer screening has been investigated and applied as a medical practice. InferRead Lung CT.AI by Infervision is a dedicated post processing application that generates CADe marks as an overlay on the original CT series intended to aid the radiologist in the detection of pulmonary nodules. This study was designed to evaluate radiologists' performance in detecting actionable nodules on chest CT when aided by InferRead.
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: True
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: