Status Approved
First Submitted Date
2019/07/10
Registered Date
2019/07/16
Last Updated Date
2019/07/27
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004147 |
---|---|
Unique Protocol ID | 2018-1251 |
Public/Brief Title | 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 |
Scientific Title | 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 |
Acronym | |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
---|---|
Board Approval Number | 2018-1251 |
Approval Date | 2018-10-14 |
Institutional Review Board Name | Asan Medical Center Institutional Review Board |
Institutional Review Board Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
Institutional Review Board Telephone | 02-3010-7166 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
---|---|
Name | Sang Min Lee |
Title | MD |
Telephone | +82-2-3010-4382 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
Contact Person for Public Queries | |
Name | Eunkyung Jung |
Title | RA |
Telephone | +82-2-515-6646 |
Affiliation | Vuno |
Address | 6F, Gangnam-daero 507, Seocho-gu, Seoul |
Contact Person for Updating Information | |
Name | Eunkyung Jung |
Title | RA |
Telephone | +82-2-515-6646 |
Affiliation | Vuno |
Address | 6F, Gangnam-daero 507, Seocho-gu, Seoul |
4. Status
Study Site | Single | |
---|---|---|
Overall Recruitment Status | Completed | |
Date of First Enrollment | 2019-03-14 Actual | |
Target Number of Participant | 228 | |
Primary Completion Date | 2019-06-07 , Actual | |
Study Completion Date | 2019-06-07 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Asan Medical Center | |
Recruitment Status | Completed | |
Date of First Enrollment | 2019-03-14 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID | HI17C2410 |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Vuno |
Organization Type | Others |
7. Study Summary
Lay Summary | Objective: This study is a single-center, randomized, corossover, and pivotal trial to evaluate the efficacy of VUNO Med – Chest X-ray for chest radiography screening. Background: Deep learning is a machine learning algorithm that learns on its own the features that reveal the data from a large amount of data. VUNO Inc. builds a deep learning model with a large amount of chest radiographs to automatically detect abnormalities. VUNO Med – Chest X-ray can simplify existing chest radiography screening procedures by analyzing chest radiographs and informing presence of abnormal findings. |
---|
8. Study Design
Study Type | Interventional Study |
---|---|
Study Purpose | Screening |
Phase | Not applicable |
Intervention Model | Cross-over |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Medical Device |
Intervention Description | VUNO Med - Chest X-ray software detects abnormalites from uploaded images |
Number of Arms | 2 |
Arm 1 |
Arm Label Group 2 |
Target Number of Participant 114 |
|
Arm Type Others |
|
Arm Description Phase 1: chest radiograph screening without CAD assistance Phase 2 (after washout): chest radiograph screening with CAD assistance |
|
Arm 2 |
Arm Label Group 1 |
Target Number of Participant 114 |
|
Arm Type Others |
|
Arm Description Phase 1: chest radiograph screening with CAD assistance Phase 2 (after washout): chest radiograph screening without CAD assistance |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (J00-J99)Diseases of the respiratory system (J98.9)Respiratory disorder, unspecified Chest radiograph screened population |
---|---|
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~No Limit |
|
Description 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 |
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 |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
---|---|---|
Primary Outcome(s) 1 | ||
Outcome | JAFROC (Jackknife Alternative Free-response Receiver Operating Characteristic curve) Figure of merit |
|
Timepoint | After phase 1 and 2 completion |
|
Secondary Outcome(s) 1 | ||
Outcome | Sensitivity |
|
Timepoint | After phase 1 and 2 completion |
|
Secondary Outcome(s) 2 | ||
Outcome | Specificity |
|
Timepoint | After phase 1 and 2 completion |
|
Secondary Outcome(s) 3 | ||
Outcome | False positive |
|
Timepoint | After phase 1 and 2 completion |
|
Secondary Outcome(s) 4 | ||
Outcome | Accuracy |
|
Timepoint | After phase 1 and 2 completion |
|
Secondary Outcome(s) 5 | ||
Outcome | AUROC (Area Under the Receiver Operating Characteristic curve) |
|
Timepoint | After phase 1 and 2 completion |
|
Secondary Outcome(s) 6 | ||
Outcome | Reading time |
|
Timepoint | After phase 1 and 2 completion |
11. Study Results and Publication
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
---|
TOP
BOTTOM
화면 최하단으로 이동