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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017083
Receipt No. R000019818
Scientific Title Narrow-band imaging versus white light for detection of diminutive colorectal adenoma using wide-view and high-definition colonoscope (HQ290ZI): A randomized controlled trial
Date of disclosure of the study information 2015/04/09
Last modified on 2019/04/02

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Basic information
Public title Narrow-band imaging versus white light for detection of diminutive colorectal adenoma using wide-view and high-definition colonoscope (HQ290ZI): A randomized controlled trial
Acronym Narrow-band imaging versus white light for detection of diminutive colorectal adenoma using wide-view and high-definition colonoscope (HQ290ZI): a randomized controlled trial
Scientific Title Narrow-band imaging versus white light for detection of diminutive colorectal adenoma using wide-view and high-definition colonoscope (HQ290ZI): A randomized controlled trial
Scientific Title:Acronym Narrow-band imaging versus white light for detection of diminutive colorectal adenoma using wide-view and high-definition colonoscope (HQ290ZI): a randomized controlled trial
Region
Japan

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

Objectives
Narrative objectives1 To evaluate ability of narrow-band imaging for detetion of diminutive colorectal adenoma using wide-view and high definition colonosope (HQ290ZI)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of narrow-band imaging versus white light imaging for diminutive adenoma detection rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 narrow-band imagaing
Interventions/Control_2 white light
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria First colonoscopy patient
patient who has been tereated all colorectal polyps in the past colonoscopy
Key exclusion criteria history of surgical resection for colorectum
inflammatory bowel deisease
Lynch syndrome
hereditary colorectal polyposis
active intestinal bleeding
colorectal stenosis
colorecatl diverticulosis
toxicic mega-colon
unsuccess of cecal insertion
poor colon creansing
antithrombotic drug
melanosis of colorectum
Target sample size 450

Research contact person
Last name of lead principal investigator
1st name Atsushi
Middle name
Last name Katagiri
Organization Showa University, Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address 35-1 Chigasaki-Chuo, Tsuzuki, Yokohama 224-8503, Japan
TEL 045-949-7000
Email katsushi0324@hotmail.com

Public contact
1st name of contact person
1st name Atsushi
Middle name
Last name Katagiri
Organization Showa University, Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address 35-1 Chigasaki-Chuo, Tsuzuki, Yokohama 224-8503, Japan
TEL +81-45-949-7000
Homepage URL
Email katsushi0324@hotmail.com

Sponsor
Institute Showa University, Northern Yokohama Hospital
Institute
Department

Funding Source
Organization Digestive Disease Center, Showa University, Northern Yokohama 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 Digestive Disease Center, Showa University, Northern Yokohama Hospital
Address 35-1 Chigasaki-Chuo, Tsuzuki, Yokohama 224-8503, Japan
Tel 045-949-7000
Email irb02syh@ofc.showa-u.ac.jp

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 昭和大学横浜市北部病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 09 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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 09 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019818

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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