UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046255 |
|---|---|
| Receipt number | R000052772 |
| Scientific Title | Examination of small polyp detection ability using a novel image-enhanced endoscopy system |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2023/06/03 10:09:55 |
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Basic information
Public title
Examination of small polyp detection ability using a novel image-enhanced endoscopy system
Acronym
TXI Video Study
Scientific Title
Examination of small polyp detection ability using a novel image-enhanced endoscopy system
Scientific Title:Acronym
TXI Video Study
Region
| Japan |
Condition
Condition
colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the polyp detection ability of white light imaging (WLI), Narrow band imaging (NBI) and texture and color enhancement imaging (TXI) using the new image-enhanced endoscopy system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the sensitivity and specificity to polyp detecting in WLI, NBI, and TXI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
colorectal mucosa or polyp in white light imaging (WLI)
Interventions/Control_2
colorectal mucosa or polyp in narrow band imaging (NBI)
Interventions/Control_3
colorectal mucosa or polyp in texture and Color Enhancement Imaging (TXI)
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
| 24 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Gastroenterologist or Gastroenterologist Resident
Key exclusion criteria
people other than inclusion criteria
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kunihiko |
| Middle name | |
| Last name | Wakamura |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1 Chigasakichuo Tsuzuki-ku Yokohama city Kanagawa Japan
TEL
045-949-7000(ext.7757)
wakamura92@gmail.com
Public contact
Name of contact person
| 1st name | Kunihiko |
| Middle name | |
| Last name | Wakamura |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1 Chigasakichuo Tsuzuki-ku Yokohama city Kanagawa Japan
TEL
045-949-7000(ext.7757)
Homepage URL
wakamura92@gmail.com
Sponsor or person
Institute
Department of Medicine, Division of Gastroenterology, Showa University, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
None
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
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555 Japan
Tel
03-3784-8129
m-rinri@ofc.showa-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | 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
39
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
| 2021 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052772
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
