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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name