UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination for educational training effects and the safety of using optical needle guide.
Title of the study (Brief title)	Examination for educational training effects and the safety of using optical needle guide.
Region	Japan

Condition
Condition	Disease which requires CVC
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, the main objective is to evaluate and investigate the educational training effects and the safety of using optical needle guide which is invented by the principal investigator.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To highly accurately puncture and the improvement.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	CVC seminar participation doctor, regident medicine and nurse.
Key exclusion criteria	n/a
Target sample size	46

Research contact person
Name of lead principal investigator	Takayuki Asao
Organization	Gunma University Initiative for Advance Research
Division name	Big Data Center for Integrative Analysis
Address	3-39-22 Showa-machi Maebashi Gunma 371-8511
TEL	027-220-8353
Email	asao@gunma-u.ac.jp

Public contact
Name of contact person	Takayuki Asao
Organization	Gunma University Initiative for Advance Research
Division name	Big Data Center for Integrative Analysis
Address	3-39-22 Showa-machi Maebashi Gunma 371-8511
TEL	027-220-8353
Homepage URL
Email	asao@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Government offices of other countries
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	2016 Year 12 Month 05 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 06 Month 10 Day
Anticipated trial start date	2016 Year 10 Month 01 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	n/a

Management information
Registered date	2016 Year 12 Month 05 Day
Last modified on	2016 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028764