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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024157
Receipt No. 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 2016/11/27

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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
Email 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
Email misawaanny@gmail.com

Sponsor
Institute Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
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
2016 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027628

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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