Clinical Performance Evaluation of Veye Lung Nodules

• Conditions: Lung; Node
• Interventions: Device: Veye Lung nodules

• Registration Number: NCT04792632
• Lead Sponsor: Aidence

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

Not available

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-03
• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Study First Posted: 2021-03-11
• Last Update Posted: 2021-03-11
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Detection accuracy	2 months	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)

Secondary Outcome Measures

Name	Time	Method
Segmentation accuracy	1 month	Demonstrate that the accuracy for segmenting actionable pulmonary nodules by the device is non-inferior to expert radiologists

Trial Locations

Locations (1)

Intrinsic Imaging; 🇺🇸 Boston, Massachusetts, United States