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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014555
Receipt No. R000016934
Scientific Title Detectability of colorectal polyp using the novel endoscopic system which a laser light source was equipped with: a multicenter randomized controlled trial
Date of disclosure of the study information 2014/07/15
Last modified on 2018/01/15

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Basic information
Public title Detectability of colorectal polyp using the novel endoscopic system which a laser light source was equipped with: a multicenter randomized controlled trial
Acronym BLI STUDY
Scientific Title Detectability of colorectal polyp using the novel endoscopic system which a laser light source was equipped with: a multicenter randomized controlled trial
Scientific Title:Acronym BLI STUDY
Region
Japan

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

Objectives
Narrative objectives1 To compare detectability of colorectal polyp using the novel endoscopic system of a laser light source with conventional endoscopic system of the xenon lamp.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The numbers of detected colorectal adenomatous lesions
Key secondary outcomes The numbers of detected colorectal any lesions
Observation time

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Endoscopic system of the laser light source
(blue laser imaging observation)
Interventions/Control_2 Endoscopic system of the xenon light source
(white light imaging observation)
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
40 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
Target sample size 1000

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroaki Ikematsu
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology & Gastrointestinal Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email hikemats@east.ncc.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hiroaki Ikematsu
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology & Gastrointestinal Oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email hikemats@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization No
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 京都府立医科大学病院(京都府)、国立がん研究センター中央病院(東京都)、国立がん研究センター東病院(千葉県)、自治医科大学付属病院(栃木県)、地域医療機能推進機構 群馬中央病院(群馬県)、東京慈恵会医科大学葛飾医療センター(東京都)、福岡大学筑紫病院(福岡県)、福島県立医科大学会津医療センター(福島県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 15 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 Main results already published
Date of protocol fixation
2014 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2015 Year 08 Month 07 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 14 Day
Last modified on
2018 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016934

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2015/08/07 150807UMIN登録データBLI.xlsx


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