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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04792632
Other study ID # Aidence01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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