Clinical Performance Evaluation of Veye Lung Nodules

Lung; Node Clinical Trial

— CPEVLN  

Official title:

Clinical Performance Evaluation of Veye Lung Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792632
• Other study ID #: Aidence01
• Status: Recruiting
• Start date: March 3, 2021
• Est. completion date: July 2021

Study information

• Verified date: March 2021
• Source: Aidence
• Contact: Joris Wakkie, Ms
• Phone: +31624561754
• Email: joris[@]aidence.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung; Node

Intervention

Device:
• Veye Lung nodules
Veye Lung Nodules

Locations

Country	Name	City	State
United States	Intrinsic Imaging	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Aidence

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Growth assessment accuracy	Demonstrate that the accuracy for determining volume change of actionable pulmonary nodules by the device is non-inferior to expert radiologists	1 month
Other	Composition classification accuracy	Demonstrate that the accuracy for classifying the composition of actionable pulmonary nodules by radiologists using the device (AIDED) is superior to that of radiologists not using the device (UNAIDED)	2 months
Primary	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)	2 months
Secondary	Segmentation accuracy	Demonstrate that the accuracy for segmenting actionable pulmonary nodules by the device is non-inferior to expert radiologists	1 month