UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051744 |
|---|---|
| Receipt number | R000059044 |
| Scientific Title | Validation study of data for evaluation of Endoscopy CAD Program on gastric lesion detection |
| Date of disclosure of the study information | 2023/07/29 |
| Last modified on | 2023/07/28 21:15:38 |
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Basic information
Public title
Validation of data for evaluation of Computer Aided Program on gastric lesion detection for endoscopes using artificial intelligence
Acronym
Validation of data for evaluation of Computer Aided Program on gastric lesion detection for endoscopes
Scientific Title
Validation study of data for evaluation of Endoscopy CAD Program on gastric lesion detection
Scientific Title:Acronym
Validation of data for evaluation of Endoscopy CAD Program
Region
| Japan |
Condition
Condition
Localized gastric lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study of methods to construct data for evaluation of Endoscopy CAD Program on gastric lesion detection
Basic objectives2
Others
Basic objectives -Others
To confirm of appropriateness of existing data as performance evaluation in order to efficiency of methods to construct data for evaluation of Endoscopy CAD Program on gastric lesion detection
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For the moving image of upper gastrointestinal endoscopy, confirmation of appropriateness of Endoscopy CAD Program on gastric lesion detection as a moving image for performance evaluation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who:
- are over the age of 20
- with early stage gastric cancer
- consent to secondary use
Key exclusion criteria
Patients who are under the age of 20
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Shiho |
| Middle name | |
| Last name | Miyauchi |
Organization
OLYMPUS Medical Systems Corp.
Division name
Safety and Efficacy Management
Zip code
192-8507
Address
2951 Ishikawa-machi, Hachioji-shi, Tokyo
TEL
042-642-2111
shiho.miyauchi@olympus.com
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Miyauchi |
Organization
OLYMPUS Medical Systems Corp.
Division name
Safety and Efficacy Management
Zip code
192-8507
Address
2951 Ishikawa-machi, Hachioji-shi, Tokyo
TEL
042-642-2111
Homepage URL
shiho.miyauchi@olympus.com
Sponsor or person
Institute
OLYMPUS Medical Systems Corp.
Institute
Department
Personal name
Funding Source
Organization
OLYMPUS Medical Systems Corp.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
OLYMPUS Corp. Institutional Review Board
Address
Shinjuku Monolith, 2-3-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
Tel
03-3340-2111
yoshiharu.ishibashi@olympus.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2023 | Year | 07 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059044
