Clinical Performance Evaluation of Veye Lung Nodules (CPEVLN)

Aidence

Status: Unknown

Conditions: Lung; Node

Treatments: Device: Veye Lung nodules

Study type: Observational

Funder types: Industry

Identifiers

NCT04792632

Aidence01

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects that underwent a CT chest scan for either lung cancer screening or routine practice

Exclusion criteria

• Subjects with >10 pulmonary nodules;
• Subjects with pulmonary mass(es) = largest axial diameter >30mm;
• Subjects with interstitial lung disease.

Trial design

350 participants in 1 patient group

Intervention

Description:

Intervention is the use of Veye Lung Nodules during the reading of the CT scans

Treatment:

Device: Veye Lung nodules