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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019200
Receipt No. 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 2019/04/04

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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
Email 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
Email cda40950@hkg.odn.ne.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Email 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 Open public recruiting
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 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022192

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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