UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054600 |
|---|---|
| Receipt number | R000062385 |
| Scientific Title | Determination of visual gaze pattern reflecting endoscopist fatigue |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2026/02/06 12:33:08 |
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Basic information
Public title
Determination of visual gaze pattern reflecting endoscopist fatigue
Acronym
Determination of visual gaze pattern reflecting endoscopist fatigue
Scientific Title
Determination of visual gaze pattern reflecting endoscopist fatigue
Scientific Title:Acronym
Determination of visual gaze pattern reflecting endoscopist fatigue
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine visual gaze pattern that is directly related to endoscopist fatigue by the analysis on visual gaze pattern during colonoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between visual gaze pattern and objective scale of endoscopist fatigue
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
Record the endoscopist's gaze position coordinate information during the colonoscopy using the real-time visual gaze pattern analysis system.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo colonoscopy.
Key exclusion criteria
Patients with inflammatory bowel disease, previous colorectal surgery, and familial adenomatous polyposis.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Gastroenterology
Zip code
272-0827
Address
6-1-14 Konodai, Ichikawa
TEL
0473751111
ishibashi-gast@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Ishibashi |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Gastroenterology
Zip code
272-0827
Address
6-1-14 Konodai, Ichikawa
TEL
0473751111
Homepage URL
ishibashi-gast@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Ichikawa Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Instituitional Review Board of International University of Health and Welfare
Address
852 Hatagada, Narita, Chiba
Tel
0476-20-7708
rinri_md@iuhw.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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 06 | Month | 07 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062385
