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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018716
Receipt No. R000021657
Scientific Title Observation of the small intestinal disease usig single-balloon enteroscopy with magnifying system and confocal laser endomicroscopy
Date of disclosure of the study information 2015/08/18
Last modified on 2017/08/19

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Basic information
Public title Observation of the small intestinal disease usig single-balloon enteroscopy with magnifying system and confocal laser endomicroscopy
Acronym Observation of the small intestinal disease usig single-balloon enteroscopy with magnifying system and confocal laser endomicroscopy
Scientific Title Observation of the small intestinal disease usig single-balloon enteroscopy with magnifying system and confocal laser endomicroscopy
Scientific Title:Acronym Observation of the small intestinal disease usig single-balloon enteroscopy with magnifying system and confocal laser endomicroscopy
Region
Japan

Condition
Condition Small intestinal disease
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficucy of the
observation for smallintestinal disease by using single balloon enteroscopy with magnifying system and probe type confocal laser endomicroscopy (pCLE).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison between endoscopic picture and pathology.
Key secondary outcomes

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 usig single-balloon enteroscopy with magnifying system and confocal laser endomicroscopy
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 1. Dignosed small intestinal disease.(require Balloon assisted enteroscopy)
2. Suspected small intestinaldisease.
(require Balloon assisted enteroscopy)
Key exclusion criteria Patient who has allergy against fluorescein.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhjiko Ogata, MD
Organization Keio University
Division name Center for diagnostic therapeutic endoscopy
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL +81-3-3353-1211
Email hogata@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Hosoe, MD
Organization Keio university
Division name Center for diagnostic therapeutic endoscopy
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL +81-3-3353-1211
Homepage URL
Email nhosoe@keio.jp

Sponsor
Institute Center for diagnostic therapeutic endoscopy
Institute
Department

Funding Source
Organization Center for diagnostic therapeutic endoscopy
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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 18 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 04 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 18 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 08 Month 18 Day
Last modified on
2017 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021657

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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