UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study about usefullness of new ultrasound machine in diagnosis and therapy for liver disease
Title of the study (Brief title)	Usefullness of new ultrasound machine
Region	Japan

Condition
Condition	liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the image and the function of the ultrasound machine which Japaneses doctors and technicians want and to contribute the ability of diagnosis and therapy for liver disease using new ultrasound machine.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of the image and the function of the ultrasound machine
Key secondary outcomes

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	In persons who recieve this study,the examination time will be prolonged for about 15 minutes.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Age 20 y.o or over 2. persons who will have the exam of ultrasound 3. persons who are not pregnant 4. The person that a written consent was provided after having received enough explanation
Key exclusion criteria	1. Age less than 20 y.o. 2. persons who are pregnant 3. persons who are judged as an inappropriate subject by the principal investigator
Target sample size	250

Research contact person
Name of lead principal investigator	Shuichiro Shiina
Organization	Juntendo University Hospital
Division name	Department of Gastroenterology
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	sshiina@juntendo.ac.jp

Public contact
Name of contact person	Yasuharu Imai
Organization	Juntendo University Hospital
Division name	Department of Gastroenterology
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	y-imai@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 08 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 27 Day
Anticipated trial start date	2017 Year 09 Month 14 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete	2018 Year 07 Month 31 Day
Date analysis concluded	2018 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 05 Day
Last modified on	2018 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032678