UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031506 |
|---|---|
| Receipt number | 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 | 2020/08/30 12:31:55 |
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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
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/
naoki.shimojima@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 30 | Day |
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
| 2020 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035971
