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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036359
Receipt No. R000041425
Scientific Title Prospective study of image acquisition time using ultra-magnifying endoscopy
Date of disclosure of the study information 2019/03/31
Last modified on 2019/05/05

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Basic information
Public title Examination of image acquisition time using ultra-magnifying endoscopy
Acronym Examination of image acquisition time
Scientific Title Prospective study of image acquisition time using ultra-magnifying endoscopy
Scientific Title:Acronym Prospective study of image acquisition time
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the time to acquire ultra-magnifying images for evaluating inflammatory activity in ulcerative colitis.
Basic objectives2 Others
Basic objectives -Others Ultra-magnifying endoscopy has two methods for the image acquisition :NBI method and staining method. We will evaluate whether the NBI method can acquire images in a shorter time than the staining method.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Superiority (shorter time) to the staining method of the NBI method
Key secondary outcomes Superiority (shorter time) to biopsy of the NBI method

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 Patients with ulcerative colitis who are clinically required to undergo colonoscopy at the Showa University Northern Yokohama Hospital.
Key exclusion criteria Patients who did not obtain consent for study participation
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Yasuharu
Middle name
Last name Maeda
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address 35-1 Chigasakichuo Tuduki-ku Yokohama
TEL +81459497000
Email yasuharumaeda610@hotmail.com

Public contact
Name of contact person
1st name Yasuharu
Middle name
Last name Maeda
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address 35-1 Chigasakichuo Tuduki-ku Yokohama
TEL +81459497000
Homepage URL
Email yasuharumaeda610@hotmail.com

Sponsor
Institute Digestive Disease Center, 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 Kanagawa-ken

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University Northern Yokohama Hospital IRB
Address 35-1 Chigasakichuo Tuduki-ku Yokohama
Tel +81459497000
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

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 31 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
2019 Year 03 Month 01 Day
Date of IRB
2019 Year 03 Month 14 Day
Anticipated trial start date
2019 Year 03 Month 31 Day
Last follow-up date
2019 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1.Time required to acquire 5 images with NBI method
2.Time required to acquire 5 images by staining method
3.Time required to obtain 1 biopsy sample

We will compare 1 with 2 and 3.

Management information
Registered date
2019 Year 03 Month 31 Day
Last modified on
2019 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041425

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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