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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007150
Receipt No. R000008304
Scientific Title The Impact of Colorectal Lesion Detection Using Narrow Band Imaging
Date of disclosure of the study information 2012/02/01
Last modified on 2013/05/02

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Basic information
Public title The Impact of Colorectal Lesion Detection Using Narrow Band Imaging
Acronym Colon NBI study
Scientific Title The Impact of Colorectal Lesion Detection Using Narrow Band Imaging
Scientific Title:Acronym Colon NBI study
Region
Japan

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

Objectives
Narrative objectives1 To clarify the number of neoplastic lesion using either white light or narrow band imaging
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the number of neoplastic lesion using either white light or narrow band imaging
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 NBI observation
Interventions/Control_2 white light observation
Interventions/Control_3 NBI observation
Interventions/Control_4 white light observation
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 The patient to perform colonoscopy
Key exclusion criteria IBD
FAP
HNPCC
A history of the colorectal surgery
Target sample size 380

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takahiro Horimatsu
Organization Graduate School of Medicine, Kyoto University
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kawahara-cho, 54, Shogoin, Sakyo-ku, Kyoto
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, Kyoto University
Division name Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
Email thorimat@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Institute
Department

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
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
2012 Year 02 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
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
2012 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 27 Day
Last modified on
2013 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008304

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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