UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054282 |
|---|---|
| Receipt number | R000061989 |
| Scientific Title | Prospective study for the investigation of performance of gastroAI model-G for transnasal endoscopy |
| Date of disclosure of the study information | 2024/05/13 |
| Last modified on | 2025/04/30 11:53:10 |
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Basic information
Public title
Prospective study for the investigation of performance of gastroAI model-G for transnasal endoscopy
Acronym
Investigation of artificial intelligence diagnostic support system for transnasal endoscopy
Scientific Title
Prospective study for the investigation of performance of gastroAI model-G for transnasal endoscopy
Scientific Title:Acronym
Prospective study for the investigation of performance of gastroAI model-G for transnasal endoscopy
Region
| Japan |
Condition
Condition
gastric epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the effectiveness of endoscopic imaging support software, gastroAI model-G, in transnasal endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Negative predictive value of gastroAI model-G in transnasal endoscopy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The endoscopic imaging support software, gastroAI model-G, is used during transnasal endoscopy.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients undergoing upper gastrointestinal endoscopy using a transnasal endoscopy.
(2) Age 20 years or older (at the time of enrollment).
(3) Patients who have given their written consent to participate in the study.
Key exclusion criteria
(1) Patients after total gastrectomy.
(2) Patients on antithrombotic drugs for whom biopsy is contraindicated.
(3) Pregnant, possibly pregnant, or lactating women.
(4) Patients with psychosis, psychiatric symptoms, or dementia that would make participation in the study difficult.
(5) Other cases deemed inappropriate by the study physician.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Nakao |
Organization
Tane General Hospital
Division name
Gastroenterology
Zip code
5500025
Address
1-12-21, Kujo-Minami, Nishi-ku, Osaka city, Osaka
TEL
0665811071
eisuke0401@gmail.com
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Nakao |
Organization
Tane General Hospital
Division name
Gastroenterology
Zip code
5500025
Address
1-12-21, Kujo-Minami, Nishi-ku, Osaka city, Osaka
TEL
0665811071
Homepage URL
eisuke0401@gmail.com
Sponsor or person
Institute
Tane General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tane General Hospital
Address
1-12-21, Kujo-Minami, Nishi-ku, Osaka city, Osaka
Tel
0665811071
eisuke0401@gmail.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
| 2024 | Year | 05 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 29 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061989
