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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013770
Receipt No. R000016074
Scientific Title Improvement of Detectability of Colorectal Polyps using Blue Laser Imaging
Date of disclosure of the study information 2014/04/21
Last modified on 2016/03/17

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Basic information
Public title Improvement of Detectability of Colorectal Polyps using Blue Laser Imaging
Acronym Improvement of Detectability of Colorectal Polyps using Blue Laser Imaging
Scientific Title Improvement of Detectability of Colorectal Polyps using Blue Laser Imaging
Scientific Title:Acronym Improvement of Detectability of Colorectal Polyps using Blue Laser Imaging
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether BLI-bright, LCI etc. by a LASER endoscope system could improve the detectability of colorectal polyps compared to white light (WL).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection score for colorectal polyps using blue laser imaging
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 Colorectal polyps more than 2mm in size with histopathological assesement
Key exclusion criteria colorectal polyps more than 20mm in size
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohisa Yoshida
Organization Kyoto Prefectural University of Medicine
Division name Department of gastroenteorlogy and hepatology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL +81-75-251-5519
Email naohisa@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohisa Yoshida
Organization Kyoto Prefectural University of Medicine
Division name Department of gastroenteorlogy and hepatology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL +81-75-251-5519
Homepage URL
Email naohisa@koto.kpu-m.ac.jp

Sponsor
Institute Department of gastroenteorlogy and hepatology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Department of gastroenteorlogy and hepatology, Kyoto Prefectural University of Medicine
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 京都府立医科大学消化器内科
福岡大学筑紫病院消化器内科

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 21 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
2014 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 01 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 Using endoscopic movies and figures, we examined polyp visibility of polyps 2-20 mm in size detected by colonoscopy with BLI, BLI-bright, LCI etc comprared to white light observation. .

Management information
Registered date
2014 Year 04 Month 21 Day
Last modified on
2016 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016074

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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