Recruiting

Lung Nodules

Sponsor:

Aidence

Code:

NCT04792632

Conditions

Lung; Node

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Veye Lung nodules

Study Details

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.

Conditions

Lung; Node

Study ID

NCT04792632

Start date

Mar 3, 2021

Status verified date

Mar, 2021

Completion date

Jul, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

Intervention

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

Interventions

Veye Lung nodules

Veye Lung Nodules

Primary outcome measure

  • Detection accuracy [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Joris Wakkie, Ms

+31624561754joris@aidence.com

Locations

Intrinsic Imaging

Recruiting

Boston, Massachusetts, United States, 01740

Contacts

Central Contact

978-634-2200Contact@IntrinsicImaging.com

More Information

Sponsor

Aidence

Last update posted

Mar 11, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aidence on 2021-03-11.