UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051304 |
|---|---|
| Receipt number | R000058499 |
| Scientific Title | Construction of Eye Tracking and Feedback System (ETF System) for improving colorectal lesion detection |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2024/03/07 08:37:17 |
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Basic information
Public title
Construction of Eye Tracking and Feedback System (ETF System) for improving colorectal lesion detection
Acronym
Construction of ETF System for improving colorectal lesion detection
Scientific Title
Construction of Eye Tracking and Feedback System (ETF System) for improving colorectal lesion detection
Scientific Title:Acronym
Construction of ETF System for improving colorectal lesion detection
Region
| Japan |
Condition
Condition
Colorectal polyp
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to construct the feedback system of endoscopist's visual gaze pattern in colonoscopy for improving adenoma detection and to optimize the system setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of adenoma per colonoscopy in the group with ETF System and the control group
Key secondary outcomes
Adenoma detection rate, Number of adenoma per colonoscopy in the right-sided colon, Adenoma detection rate in the right-sided colon, Sessile serrated lesion detection rate, Withdrawal time during colonoscopy, Visual gaze pattern distribution of endoscopist, Visual gaze pattern during treatment of colorectal polyp, Visual gaze velocity of endoscopist, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
ETF System equipped group 1 (wide region of interest for feedback)
Interventions/Control_2
ETF System equipped group 2 (middle region of interest for feedback)
Interventions/Control_3
ETF System equipped group 3 (narrow region of interest for feedback)
Interventions/Control_4
Control group (without ETF System)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Those who undergoes the colonoscopy
2. Those whose performance status is 0,1 or 2
3. Those who recieves an explanation about the entry for this study and obtain his/her consent in a document
Key exclusion criteria
1. Those who received colorectal surgery (Exclude an appendix excision)
2. Those with inflammatory bowel disease (Ulcerative colitis, Crohn disease and Behcet disease)
3. Those with hereditary or non-hereditary polyposis
4. Those with hereditary nonpolyposis colorectal cancer (Lynch syndrome)
5. Those with severe diverticulum that infers safe examination
6. Those who cannot take pretreatment medication before colonoscopy
7. Those who has an allergy for pretreatment medication or sedative agent
8. Those whose colorectal adenoma or colorectal cancer has been already identified
9. Those who is pregnant
10.Those who is breastfeeding
11.Those whose consent cannot be obtained
12.Those who is confirmed to be inappropriate for participation by the doctor in charge of the study
13.Those who has already been enrolled for this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Gastroenterology and Hepatology
Zip code
272-0827
Address
6-1-14 Konodai Ichikawa-City Chiba
TEL
047-375-1111
s.sho.salubriter.mail@gmail.com
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Nagai |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Gastroenterology and Hepatology
Zip code
272-0827
Address
6-1-14 Konodai Ichikawa-City Chiba
TEL
047-375-1111
Homepage URL
https://ichikawa.iuhw.ac.jp
nagaim@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Ichikawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Ethics Comittee of Chiba area of International Universiy of Health and Welfare
Address
4-3 Kodunomori Narita-City 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
国際医療福祉大学市川病院
Other administrative information
Date of disclosure of the study information
| 2023 | 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
200
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 09 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058499
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