Clinical Performance Evaluation of Veye Lung Nodules

Aidence350 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Lung; Node

Interventions

Veye Lung nodulesDEVICE

Veye Lung Nodules

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Intrinsic Imaging

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Detection accuracy

Demonstrate that the accuracy for detecting actionable pulmonary nodules by radiologists using the device (AIDED) is superior to that of radiologists not using the device (UNAIDED)

Time frame: 2 months

Secondary Outcomes

Segmentation accuracy

Demonstrate that the accuracy for segmenting actionable pulmonary nodules by the device is non-inferior to expert radiologists

Time frame: 1 month

Central Contacts

Joris Wakkie, Ms

CONTACT

+31624561754 joris@aidence.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.