A single-center, randomized, crossover and retrospective pivotal trial to evaluate the efficacy of VUNO Med – Chest X-ray in screening of abnormalities on chest radiograph

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004147

Enrollment

228

Registered

2019-07-16

Start date

2019-03-14

Completion date

Unknown

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : VUNO Med - Chest X-ray software detects abnormalites from uploaded images

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adults over 19 years old who underwent chest radiography screening from Jan 2016 to Dec 2017 2) Abnormal lung findings from computed tomography within 1 day of chest radiography screening * If one or more of the following is found, it is considered abnormal. However, pneumothorax or effusion may be included even without computed tomography results. - 1 ~ 3 cm sized nodule - Consolidation - Pneumothorax - Effusion - Interstitial opacity

Exclusion criteria

Exclusion criteria: 1) Computed tomography findings cannot be verified in medical records (except pneumothorax or effusion) 2) A person who is considered difficult to participate in this trial, as determined by the investigators

Design outcomes

Primary

Measure	Time frame
JAFROC (Jackknife Alternative Free-response Receiver Operating Characteristic curve) Figure of merit	—

Secondary

Measure	Time frame
Sensitivity;Specificity;False positive;Accuracy;AUROC (Area Under the Receiver Operating Characteristic curve);Reading time	—

Countries

Korea, Republic of

Contacts

Public ContactEunkyung Jung

Vuno

eunkyung.linda@gmail.com+82-2-515-6646

Outcome results