Clinical Performance Evaluation of Veye Lung Nodules (CPEVLN)

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 Overview

• Status: Recruiting
• Conditions: Lung; Node
• Intervention / Treatment: Device: Veye Lung nodules

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Joris Wakkie, Ms; Phone Number: +31624561754; Email: joris@aidence.com

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 01740
      • Recruiting
      • Intrinsic Imaging
      • Contact: Central Contact; Phone Number: 978-634-2200; Email: Contact@IntrinsicImaging.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

US adult population that received a CT chest scan either as part of a lung cancer screening program or during routine practice

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; Intervention is the use of Veye Lung Nodules during the reading of the CT scans	Device: Veye Lung nodules; Veye Lung Nodules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Segmentation accuracy	Demonstrate that the accuracy for segmenting actionable pulmonary nodules by the device is non-inferior to expert radiologists	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Aidence

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Aidence01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No