UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024157 |
|---|---|
| Receipt number | R000027628 |
| Scientific Title | A pilot study of acquisition rate of computer diagnosis based on endocytoscopy for trainee endoscopist |
| Date of disclosure of the study information | 2016/09/26 |
| Last modified on | 2023/10/01 16:59:34 |
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Basic information
Public title
A pilot study of acquisition rate of computer diagnosis based on endocytoscopy for trainee endoscopist
Acronym
A study of acquisition rate of EC-CAD
Scientific Title
A pilot study of acquisition rate of computer diagnosis based on endocytoscopy for trainee endoscopist
Scientific Title:Acronym
A study of acquisition rate of EC-CAD
Region
| Japan |
Condition
Condition
colorectal cacner, colorectal adenoma, colorectal hyperplastic polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate whether the trainee endoscopist can obtain computer diagnosis for colotectal lesion or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An acquisition rate of computer diganosis (staining) for trainee endoscopist
Key secondary outcomes
1. An acquisition rate of computer diganosis (NBI) for trainee endoscopist
2. An acquisition rate of computer diganosis (staining and NBI) for expert endoscopist
3. An acquisition rate of EC image (staining and NBI).
4. An acquisition rate of computer diagnosis according to the size.
5. An acquisition rate of computer diagnosis according to the location.
6. Diagnostic accuracy of endoscopist based on computer diagnosis.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A patient who underwent endocytoscopy based computer diagnosis
Key exclusion criteria
taking anti-platelet or anti-coagulant, poor bowel preparation, inflammatory bowel disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Misawa |
Organization
Showa University Norhtern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-tyuo. Yokohama-shi, JPN
TEL
045-949-7000
misawaanny@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Misawa |
Organization
Showa University Norhtern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-tyuo. Yokohama-shi, JPN
TEL
045-949-7000
Homepage URL
misawaanny@gmail.com
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 09 | Month | 26 | 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
| 2016 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is to evaluate the acquisition rate of computer diagnosis
Management information
Registered date
| 2016 | Year | 09 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027628
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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