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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027290
Receipt No. R000031270
Scientific Title Efficacy of using virtual reality (VR) simulator in determining port arrangement of endoscopic surgery.
Date of disclosure of the study information 2017/07/01
Last modified on 2017/09/08

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Basic information
Public title Efficacy of using virtual reality (VR) simulator in determining port arrangement of endoscopic surgery.
Acronym Efficacy of using virtual reality (VR) simulator in determining port arrangement of endoscopic surgery.
Scientific Title Efficacy of using virtual reality (VR) simulator in determining port arrangement of endoscopic surgery.
Scientific Title:Acronym Efficacy of using virtual reality (VR) simulator in determining port arrangement of endoscopic surgery.
Region
Japan

Condition
Condition Diseases requiring endoscopic surgery
Classification by specialty
Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using a virtual thoracic or abdominal
cavity model created with the virtual
reality simulator based on patient's CT
or MRI data, simulate the appropriate port placement before endoscopic surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Smooth surgical operation
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 The port arrangement is determined by the simulator.
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
0 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria All patients before endoscopic surgery (thoracoscopic surgery and laparoscopic surgery) imaged CT or MRI for medical purposes before surgery.
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroo Uchida
Organization Nagoya University Graduate School of Medicine
Division name Pediaric surgery
Zip code
Address 65 Tsurumai, Showa, Nagoya
TEL 052-744-2959
Email hiro2013@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Yokota
Organization Nagoya University Graduate School of Medicine
Division name Pediaric surgery
Zip code
Address 65 Tsurumai, Showa, Nagoya
TEL 052-744-2959
Homepage URL
Email k-yokota@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 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 Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 09 Day
Last modified on
2017 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031270

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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