UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of Learning Effect of Transthoracic Echocardiography Simulator
Title of the study (Brief title)	Assessment of Learning Effect of Transthoracic Echocardiography Simulator
Region	Japan

Condition
Condition	Heart Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study evaluates the Learning Effect of Transthoracic Echocardiography Simulator for Medical Students.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The skill of obtaining echocardiographic images just after learning
Key secondary outcomes	1)The skill of reading echocardiographic images just after learning 2)Operability of echocardiography simulator

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Learning for one hour by transthoracic echocardiography simulator (Vimedix,CAE Healthcare)
Interventions/Control_2	Learning for one hour by real machine (Aplio XG,Toshiba Medical Systems Corporation) and lecture
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)Students who participate in clinical clerkship program at Chiba University Hospital. 2)Students who consent in writing to this study with enough understanding.
Key exclusion criteria	1)Students who experienced professional education about echocardiography. 2)Students judged as being inappropriate for the subjects of the study by investigators.
Target sample size	54

Research contact person
Name of lead principal investigator	Yoshio Kobayashi
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL	043-222-7171
Email	yoshio.kobayashi@wonder.ocn.ne.jp

Public contact
Name of contact person	Keiichiro Miura
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	markone@hospital.chiba-u.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Ciba University Hospital Health Professional Development Center
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	2016 Year 03 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 10 Day
Anticipated trial start date	2016 Year 03 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 03 Month 12 Day
Last modified on	2017 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024646