Clinical Performance Evaluation of Veye Lung Nodules

NCT ID: NCT04792632

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-03

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung; Node

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Intervention

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

Veye Lung nodules

Intervention Type DEVICE

Veye Lung Nodules

Interventions

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Veye Lung nodules

Veye Lung Nodules

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aidence

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Intrinsic Imaging

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joris Wakkie, Ms

Role: CONTACT

+31624561754

Facility Contacts

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Central Contact

Role: primary

978-634-2200

Other Identifiers

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Aidence01

Identifier Type: -

Identifier Source: org_study_id

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