UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053048 |
|---|---|
| Receipt number | R000059551 |
| Scientific Title | Multi-center, observational study of the effectiveness of image-enhanced endoscopy in observing the gastro-esophageal junction |
| Date of disclosure of the study information | 2023/12/10 |
| Last modified on | 2023/12/10 12:04:33 |
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Basic information
Public title
Evaluation of the effectiveness of image-enhanced endoscopy in observing the gastro-esophageal junction
Acronym
Evaluation of the effectiveness of IEE in GOJ
Scientific Title
Multi-center, observational study of the effectiveness of image-enhanced endoscopy in observing the gastro-esophageal junction
Scientific Title:Acronym
Multi-center, observational study of the effectiveness of IEE in GOJ
Region
| Japan |
Condition
Condition
Barrett's esophagus
Classification by specialty
| Gastroenterology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to objectively evaluate the visibility of IEE observation to WLI, this study aims to validate the best IEE for identification of DEPV by having multiple endoscopists evaluate it using endoscopic still images and comparing the results by objective indices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visibility (visibility of DEPV) obtained by our own image evaluation method
Key secondary outcomes
Distance-variance (DEPV visibility reproducibility) obtained by a proprietary image evaluation method
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
Ten physicians who routinely perform upper gastrointestinal endoscopy to observe the GOJ
Key exclusion criteria
Physicians deemed inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ono |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Department of Gastroenterology and Gastrointestinal Endoscopy
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-1141
satono.tky@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Ono |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Department of Gastroenterology and Gastrointestinal Endoscopy
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-1141
Homepage URL
satono.tky@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-1141
chiken@tmghig.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
| 2023 | Year | 12 | Month | 10 | 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 | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None specified
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/icdr_e/ctr_view.cgi?recptno=R000059551
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| Registered date | File name |
| Research case data | |
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