UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019200 |
|---|---|
| Receipt number | R000022192 |
| Scientific Title | Study for the evaluation of the usefulness of the ultraonogrphy for functional gastrointestinal disorders. |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2019/10/17 13:17:13 |
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Basic information
Public title
Study for the evaluation of the usefulness of the ultraonogrphy for functional gastrointestinal disorders.
Acronym
Evaluation of the utility of ultrasonography for functional gastrointestinal disorders.
Scientific Title
Study for the evaluation of the usefulness of the ultraonogrphy for functional gastrointestinal disorders.
Scientific Title:Acronym
Evaluation of the utility of ultrasonography for functional gastrointestinal disorders.
Region
| Japan |
Condition
Condition
functional gastrointestinal disorders
Classification by specialty
| Gastroenterology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate utility of ultrasonography for functional gastrointestinal disorders.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between ultrasonographic paramiters and patient's symptoms.
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo abdominal ultrasonography.
Key exclusion criteria
Patienst whom doctors judged to be inadequate.
Patient who dose not agree with this study.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Manabe |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography
Zip code
7010192
Address
Matsushima 577, Kurashiki city, Okayama
TEL
086-462-1111
cda40950@hkg.odn.ne.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Manabe |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography
Zip code
701-0192
Address
Matsushima 577, Kurashiki city
TEL
086-462-1111
Homepage URL
cda40950@hkg.odn.ne.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
non
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
Kawasaki Medical School
Address
577 Matsushima, Kurashiki
Tel
0864621111
kmsrec@med.kawasaki-m.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
| 2015 | Year | 10 | Month | 01 | 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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Crosssectional study
Patients' background, symptoms, ultrasonographic parameters
Management information
Registered date
| 2015 | Year | 10 | Month | 01 | Day |
Last modified on
| 2019 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022192
