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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031506
Receipt No. R000035971
Scientific Title Visualization of enteric nervous system by confocal laser endomicroscopy
Date of disclosure of the study information 2018/03/28
Last modified on 2018/02/27

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Basic information
Public title Visualization of enteric nervous system by confocal laser endomicroscopy
Acronym Visualization of ENS by CLE
Scientific Title Visualization of enteric nervous system by confocal laser endomicroscopy
Scientific Title:Acronym Visualization of ENS by CLE
Region
Japan

Condition
Condition Hirschsprung's disease
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Visualization of enteric nervous system by confocal laser endomicroscopy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety of this experiment
Key secondary outcomes decide the appropriate location to be resected in the operation for Hirschsprung disease.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 inject cresyl violet
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
1 years-old <=
Age-upper limit
6 years-old >=
Gender Male
Key inclusion criteria patients undergoing a surgery for
Hirschsprung's disease
Key exclusion criteria necrosis of the intestine
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Shimojima
Organization Tokyo Metropolitan Children's Medical Center
Division name Surgery
Zip code
Address 2-8-29 Musashidai Fuchu Tokyo
TEL 0423005111
Email naoki.shimojima@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Shimojima
Organization Tokyo Metropolitan Children's Medical Center
Division name Surgery
Zip code
Address 2-8-29 Musashidai Fuchu Tokyo
TEL 0423005111
Homepage URL http://www.byouin.metro.tokyo.jp/shouni/
Email naoki.shimojima@gmail.com

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 東京都立小児総合医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 28 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 02 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
2018 Year 02 Month 27 Day
Last modified on
2018 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035971

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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