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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017835
Receipt No. R000020664
Scientific Title The assessment of insertion improvement by ultra-small caliber single balloon endoscope in difficult cases
Date of disclosure of the study information 2015/06/08
Last modified on 2015/06/09

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Basic information
Public title The assessment of insertion improvement by ultra-small caliber single balloon endoscope in difficult cases
Acronym ultra-small caliber SBE
Scientific Title The assessment of insertion improvement by ultra-small caliber single balloon endoscope in difficult cases
Scientific Title:Acronym ultra-small caliber SBE
Region
Japan

Condition
Condition difficult insertion cases by standard SBE
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Improvement of endoscopic insertion
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Insertion improvement changing from standard SBE(SIF-Q260) to ultra-small caliber SBE(SIF-Y0006)
Key secondary outcomes safety, insertion time and length of both SBE

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 change to SIF-Y0006 scope
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The insertion length below 1m using SIF-Q260
Key exclusion criteria In case of the deeper insertion is considered as dageourous or not perferable

In casde of not preferable using SIF-Y0006
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Endo
Organization OFUNA CHUO HOSPITAL
Division name G.I./IBD center
Zip code
Address 6-2-24 Ofuna, Kamakura, kanagawa, Japan
TEL 0467-45-2111
Email yutaka-endo@ofunachuohp.net

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Endo
Organization OFUNA CHUO HOSPITAL
Division name G.I./IBD center
Zip code
Address 6-2-24 Ofuna, Kamakura, kanagawa, Japan
TEL 0467-45-2111
Homepage URL
Email yutaka-endo@ofunachuohp.net

Sponsor
Institute GI/IBD center, Ofuna Chou hospital
Institute
Department

Funding Source
Organization olympus company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Endoscopy University Hospital of Medicine Tokyo Medical and Dental University
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
2015 Year 06 Month 08 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
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 08 Day
Last follow-up date
2016 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 08 Day
Last modified on
2015 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020664

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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