UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054679 |
|---|---|
| Receipt number | R000062477 |
| Scientific Title | Study on color universal design of gastrointestinal endoscopy evaluation images taking into account color vision characteristics. |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/01/06 11:54:29 |
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Basic information
Public title
Study on color universal design of gastrointestinal endoscopy evaluation images taking into account color vision characteristics.
Acronym
Color universal design for gastrointestinal endoscopy.
Scientific Title
Study on color universal design of gastrointestinal endoscopy evaluation images taking into account color vision characteristics.
Scientific Title:Acronym
Color universal design for gastrointestinal endoscopy.
Region
| Japan |
Condition
Condition
Color vision deficiency (CVD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The visibility of white light images, indigocarmine spray images and image-enhanced endoscopic images for people with color vision deficiency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in visibility of white light and indigocarmine spray images and image-enhanced endoscopy images according to color vision characteristics.
Key secondary outcomes
(1) Search for factors affecting visibility
(2) Color difference between the lesion site and the surrounding mucosa
(3) Color difference between blood vessels and surrounding mucosa
(4) Age of the subject
(5) Sex of the subject
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who have already been tested by the Organisation for their own color vision characteristics using the Ishihara method or other methods, and who have participated in the promotion of color universal design in other fields.
Key exclusion criteria
(1) Persons who do not wish to consent to this research
(2) Those who are under 18 years of age
(3) Persons who have already been tested for their colour vision characteristics by the CUDO Organisation and have not been informed of their own characteristics in advance.
(4) Persons who are judged to be unsuitable as subjects for this study by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Ohno |
Organization
Kyorin University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
181-8611
Address
Shinkawa 6-20-2 , Mitaka-shi, Tokyo
TEL
0422-47-5511
akikoohno@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Ohno |
Organization
Kyorin University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
181-8611
Address
Shinkawa 6-20-2 , Mitaka-shi, Tokyo
TEL
0422-47-5511
Homepage URL
akikoohno@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Color universal design organization
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University School of Medicine
Address
Shinkawa 6-20-2 , Mitaka-shi, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-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
杏林大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | 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
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
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 19 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 19 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
When this research is completed, it will be reported to UMIN and the Kyorin University Ethics Committee without delay. The results of this research will be presented at international and national conferences and papers will be published. In doing so, any information that can identify specific individuals will not be included.
Management information
Registered date
| 2024 | Year | 06 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062477
