NCT04792632

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 8, 2021

Last Update Submit

March 8, 2021

Conditions

Lung; Node

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Segmentation accuracy

    1 month

Other Outcomes (2)

  • Growth assessment accuracy

    1 month

  • Composition classification accuracy

    2 months

Study Arms (1)

Intervention

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

Device: Veye Lung nodules

Interventions

Veye Lung nodulesDEVICE

Veye Lung Nodules

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \- Subjects that underwent a CT chest scan for either lung cancer screening or routine practice

You may not qualify if:

  • Subjects with \>10 pulmonary nodules;
  • Subjects with pulmonary mass(es) = largest axial diameter \>30mm;
  • Subjects with interstitial lung disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intrinsic Imaging

Boston, Massachusetts, 01740, United States

RECRUITING

Central Study Contacts

Joris Wakkie, Ms

CONTACT

+31624561754joris@aidence.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

March 3, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)