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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016596
Receipt No. R000019260
Scientific Title Validation of the criterion of differential diagnosis for colorectal polyps using magnifying NBI classification
Date of disclosure of the study information 2015/02/23
Last modified on 2015/02/25

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Basic information
Public title Validation of the criterion of differential diagnosis for colorectal polyps using magnifying NBI classification
Acronym Validation of the criterion of differential NBI diagnosis
Scientific Title Validation of the criterion of differential diagnosis for colorectal polyps using magnifying NBI classification
Scientific Title:Acronym Validation of the criterion of differential NBI diagnosis
Region
Japan

Condition
Condition colorectal polyp
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Validation of the criterion of differential magnifying NBI diagnosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Specificity for the diminutive colorectal polyps
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients underwent magnifying colonoscopy
Key exclusion criteria Patient with no polyps, multiple polyps, IBD and hereditary disease.

Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sano Yasushi
Organization Sano Hospital
Division name GI center/Institute of Minimally-invasive Endoscopic Care
Zip code
Address 2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo, 655-0031, Japan
TEL 078-785-1000
Email ys_endoscopy@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Iwatate Mineo
Organization Sano Hospital
Division name GI center/Institute of Minimally-invasive Endoscopic Care
Zip code
Address 2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo, 655-0031, Japan
TEL 078-785-1000
Homepage URL
Email m.iwatate15@gmail.com

Sponsor
Institute Sano Hospital
Institute
Department

Funding Source
Organization Sano Hospital
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
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
2015 Year 02 Month 23 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 Preinitiation
Date of protocol fixation
2015 Year 02 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Magnifying NBI diagnosis

Management information
Registered date
2015 Year 02 Month 21 Day
Last modified on
2015 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019260

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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