UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054466 |
|---|---|
| Receipt number | R000061611 |
| Scientific Title | Efficacy of Endoscopic Screening with Artificial Intelligence for Gastric Tumors |
| Date of disclosure of the study information | 2024/05/24 |
| Last modified on | 2024/05/23 15:53:52 |
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Basic information
Public title
Efficacy of Endoscopic Screening with Artificial Intelligence for Gastric Tumors
Acronym
Efficacy of Endoscopic Screening with Artificial Intelligence for Gastric Tumors
Scientific Title
Efficacy of Endoscopic Screening with Artificial Intelligence for Gastric Tumors
Scientific Title:Acronym
Efficacy of Endoscopic Screening with Artificial Intelligence for Gastric Tumors
Region
| Japan |
Condition
Condition
Gastric tumor
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examine the usefulness of screening upper gastrointestinal endoscopy combined with artificial intelligence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether the endoscopy screening method using an artificial intelligence system reduces the examination time compared to the method using a magnification system.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention: Endoscopy with Artificial Intelligence system
Interventions/Control_2
Control: Endoscopy with magnification function
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following criteria must be met for patients to be included:
1. Patients suspected of having upper gastrointestinal tumors and scheduled for an upper gastrointestinal endoscopy screening test under sedation.
2. Patients aged 18 and over.
3. Patients who have given written consent.
Key exclusion criteria
Patients will be excluded if they meet any of the following criteria:
1. Patients known to have had poor sedation during previous endoscopic examinations.
2. Patients with sleep apnea syndrome, heart failure, or unstable hemodynamics where sedation during the examination is deemed hazardous.
3. Patients for whom endoscopic examination is generally contraindicated (such as those with ileus, gastrointestinal perforation, severe respiratory diseases, or cardiovascular diseases).
4. Other patients who are deemed inappropriate for participation in this study due to serious complications or other reasons.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Minoda |
Organization
Kyushu University Hospital
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5286
minoda.yosuke.633@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Minoda |
Organization
Kyushu University Hospital
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5286
Homepage URL
minoda.yosuke.633@m.kyushu-u.ac.jp
Sponsor or person
Institute
kyushu university
Institute
Department
Personal name
Funding Source
Organization
Kyushu university
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
Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
0926425082
byskenkyu@jimu.kyushu-u.ac.jp
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 | 24 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | 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 | 05 | Month | 23 | Day |
Last modified on
| 2024 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061611
