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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025505
Receipt No. R000029352
Scientific Title Randomized, Back-to-Back Trial of New Generation of NBI (HQ290) for the Detection of Colorectal Polyps
Date of disclosure of the study information 2017/01/03
Last modified on 2017/01/03

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Basic information
Public title Randomized, Back-to-Back Trial of New Generation of NBI (HQ290)
for the Detection of Colorectal Polyps
Acronym Randomized, Back-to-Back Trial of New Generation of NBI (HQ290)
for the Detection of Colorectal Polyps
Scientific Title Randomized, Back-to-Back Trial of New Generation of NBI (HQ290)
for the Detection of Colorectal Polyps
Scientific Title:Acronym Randomized, Back-to-Back Trial of New Generation of NBI (HQ290)
for the Detection of Colorectal Polyps
Region
Asia(except Japan)

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

Objectives
Narrative objectives1 To compare polyp miss rates of the 290-NBI colonoscopy with high-definition white light with wide angle (CF-HQ 290) colonoscopy in patients undergoing colonoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Polyp and adenoma miss rates
Key secondary outcomes Polyp and adenoma detection rates
Factors associated with polyp miss rate

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 We used NBI-290 during colonoscopy.
Interventions/Control_2 We used wide angle white light colonoscopy.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Consecutive patients undergoing colonoscopy
1) Diagnostic work up
2) Surveillance of colorectal polyps
3) Colorectal cancer screening
Key exclusion criteria Famillial colorectal cancer syndrome (FAP or HNP)
Personal history of colorectal cancer or inflammatory bowel disease
Previous colonic resection
Target sample size 1000

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Bong Min Ko
Organization Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea
Division name Digestive Disease Center and Research Institute
Zip code
Address SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL +82-32-621-5094
Email koppa9445@schmc.ac.kr

Public contact
1st name of contact person
1st name
Middle name
Last name Hyeon Jeong Goong
Organization Department of Internal Medicine, SoonChunHyang University
Division name Digestive Disease Center and Research Institute
Zip code
Address SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL +82-32-621-5094
Homepage URL
Email goong@schmc.ac.kr

Sponsor
Institute SoonChunHyang University, school of medicine
Institute
Department

Funding Source
Organization There is no funding source.
Organization
Division
Category of Funding Organization Other
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
2017 Year 01 Month 03 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
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 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

Management information
Registered date
2017 Year 01 Month 03 Day
Last modified on
2017 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029352

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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