Lung; NodeCPEVLNNCT04792632
Clinical Performance Evaluation of Veye Lung Nodules
An observational study of Lung; Node, run by Aidence at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung; Node
- What is being tested?
- Veye Lung nodules
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: US adult population that received a CT chest scan either as part of a lung cancer screening program or during routine practice
Who may be able to join
- Subjects that underwent a CT chest scan for either lung cancer screening or routine practice
Who cannot join
- Subjects with >10 pulmonary nodules;
- Subjects with pulmonary mass(es) = largest axial diameter >30mm;
- Subjects with interstitial lung disease.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intrinsic Imaging
Boston, Massachusetts, 01740
Central Contact, 978-634-2200, Contact@IntrinsicImaging.com
About this study
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
- Being tested
- Veye Lung nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veye Lung nodulesDevice
Veye Lung Nodules
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Intervention is the use of Veye Lung Nodules during the reading of the CT scans Receives: Device: Veye Lung nodules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 months
Secondary outcomes (1)
Segmentation accuracy
Demonstrate that the accuracy for segmenting actionable pulmonary nodules by the device is non-inferior to expert radiologists
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start3 Mar 2021
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung; NodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aidence
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792632
- Sponsor's protocol ID
- Aidence01
- Acronym
- CPEVLN
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of Veye Lung Nodules
- ClinicalTrials.gov ID
- NCT04792632
- Acronym / sponsor ID
- CPEVLN / Aidence01
- Conditions
- Lung; Node
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- AidenceIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Device: Veye Lung nodulesIntervention is the use of Veye Lung Nodules during the reading of the CT scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- US adult population that received a CT chest scan either as part of a lung cancer screening program or during routine practice
Key inclusion criteria (1 listed)
- Subjects that underwent a CT chest scan for either lung cancer screening or routine practice
Key exclusion criteria (3 listed)
- Subjects with >10 pulmonary nodules;
- Subjects with pulmonary mass(es) = largest axial diameter >30mm;
- Subjects with interstitial lung disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veye Lung nodulesVeye Lung Nodules | Device | Intervention |
Primary outcome
Detection accuracy
Time frame: 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)
1 secondary outcome
Segmentation accuracy
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung; Node, run by Aidence at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joris Wakkie, Ms (+31624561754, joris@aidence.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection accuracy (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.