CPEVLN: Clinical Performance Evaluation of Veye Lung Nodules

Sponsor

Aidence (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04792632

Collaborator

(none)

350

Enrollment

Location

3.9

Anticipated Duration (Months)

88.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung; Node	Device: Veye Lung nodules

Study Design

Study Type:

Observational

Anticipated Enrollment :

350 participants

Observational Model:

Case-Crossover

Time Perspective:

Retrospective

Official Title:

Clinical Performance Evaluation of Veye Lung Nodules

Actual Study Start Date :

Mar 3, 2021

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Growth assessment accuracy [1 month]
Demonstrate that the accuracy for determining volume change of actionable pulmonary nodules by the device is non-inferior to expert radiologists
Composition classification accuracy [2 months]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intrinsic Imaging	Boston	Massachusetts	United States	01740

Sponsors and Collaborators

Aidence

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aidence

ClinicalTrials.gov Identifier:

NCT04792632

Other Study ID Numbers:

Aidence01

First Posted:

Mar 11, 2021

Last Update Posted:

Mar 11, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Mar 11, 2021