UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046855 |
|---|---|
| Receipt number | R000053448 |
| Scientific Title | Endoscopic valuation study about the visibility of bleeding points by a novel image enhancement |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2024/02/09 10:38:20 |
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Basic information
Public title
Endoscopic valuation study about the visibility of bleeding points by a novel image enhancement
Acronym
Endoscopic valuation study about the visibility of bleeding points by a novel image enhancement
Scientific Title
Endoscopic valuation study about the visibility of bleeding points by a novel image enhancement
Scientific Title:Acronym
Endoscopic valuation study about the visibility of bleeding points by a novel image enhancement
Region
| Japan |
Condition
Condition
Gastrointestinal tumors (adenomas, cancer)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By using offline video images, we evaluate whether the image processing technique can increase the endoscopic visibility of bleeding points compared with the conventional white light images.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
We compare the visibility of a bleeding point between the original and the processed images using a 5-point Likert scale.
Key secondary outcomes
1, we calculate the average distance between a bleeding point and its surround in 3D color space and compare its color differences between the original and the processed images.
2, We compare the time until finding a bleeding point between the original and the processed images.
3, We evaluate whether the endoscopist's experience affects the subjective evaluation and the time until finding a bleeding point.
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
1. Patients provided safety endotherapy
2. Patient who will not refuse
Key exclusion criteria
Unsuitable conditions found by a doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
+81562932324
yoshiki.hirooka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Funasaka |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
+81562932324
Homepage URL
k-funa@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University hospital
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Fujita Health University IRB
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
Tel
+81562932865
f-irb@fujita-hu.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
| 2022 | Year | 02 | Month | 28 | 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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study deals with only endoscopic images without personal information. Patients could withdraw from the survey via the opt-out method provided on the hospital website.
Management information
Registered date
| 2022 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053448
