UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053047 |
|---|---|
| Receipt number | R000060523 |
| Scientific Title | Study on the Improvement of Esophageal Achalasia Diagnosis Accuracy by Artificial Intelligence in Endoscopy |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2023/12/10 09:49:14 |
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Basic information
Public title
Clinical impact of artificial intelligence (AI) on endoscopic diagnosis for esophageal achalasia
Acronym
AI Esophageal Achalasia Diagnosis Study
Scientific Title
Study on the Improvement of Esophageal Achalasia Diagnosis Accuracy by Artificial Intelligence in Endoscopy
Scientific Title:Acronym
AI Esophageal Diagnosis Accuracy Study
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
Esophageal achalasia
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to verify whether there is an additional effect of diagnosis by Achalasia CAD for non-experienced and experienced doctors in international major facilities.
Basic objectives2
Others
Basic objectives -Others
The another objective is to verify the diagnostic ability of endoscopists (humans) for achalasia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The additional effect of diagnosis by Achalasia CAD among non-experienced doctors
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
･Individuals diagnosed with achalasia.
･Among those diagnosed with non-achalasia during the same period, those with video records available, and for whom multiple endoscopists have confirmed the diagnosis of non-achalasia based on the recorded videos,and who have been deemed suitable for AI training.
･Age is not a criterion.
Doctors
Physicians who wish to read images and have obtained consent (age 20 and above).
Key exclusion criteria
Individuals deemed ineligible by the principal investigator or researchers.
Target sample size
138
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Hasegawa |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
814-0133
Address
7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0133, Japan
TEL
092-801-1011
hiro.shiwaku@gmail.com
Public contact
Name of contact person
| 1st name | Hironari |
| Middle name | |
| Last name | Shiwaku |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
814-0133
Address
7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0133, Japan
TEL
092-801-1011
Homepage URL
hiro.shiwaku@gmail.com
Sponsor or person
Institute
Fukuoka University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Fukuoka University - Medical Ethics Review Board
Address
7-45-1, Nanakuma, Jyounan-ku, Fukuoka, 814-0133, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-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
| 2025 | Year | 01 | Month | 01 | 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
133
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
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 12 | Month | 10 | Day |
Last modified on
| 2023 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060523
