Viewing Study NCT04792632


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Study NCT ID: NCT04792632
Status: UNKNOWN
Last Update Posted: 2021-03-11
First Post: 2021-03-08
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Clinical Performance Evaluation of Veye Lung Nodules
Sponsor: Aidence
Organization:

Study Overview

Official Title: Clinical Performance Evaluation of Veye Lung Nodules
Status: UNKNOWN
Status Verified Date: 2021-03
Last Known Status: RECRUITING
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: CPEVLN
Brief Summary: Veye Lung Nodules (Aidence B.V., Amsterdam, the Netherlands) is a medical software device that is intended to assist radiologists with pulmonary nodule management on CT chest scans.

This clinical trial aims to assess the clinical performance of Veye Lung nodules via a standalone performance evaluation and a reader study.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
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?: False
Is an FDA AA801 Violation?: