UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027290 |
|---|---|
| Receipt number | 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 | 2022/11/14 17:13:33 |
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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 | Uchida |
| Middle name | |
| Last name | Hiroo |
Organization
Nagoya University Graduate School of Medicine
Division name
Pediaric surgery
Zip code
4668550
Address
65 Tsurumai, Showa, Nagoya
TEL
052-744-2959
hiro2013@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinari |
| Middle name | |
| Last name | Hinoki |
Organization
Nagoya University Graduate School of Medicine
Division name
Rare/Intractable Cancer Analysis Reserch
Zip code
4668550
Address
65 Tsurumai, Showa, Nagoya
TEL
052-744-2959
Homepage URL
hinoki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
ethics committee
Address
65 Tsurumai, Showa, Nagoya
Tel
059-741-2111
ethics@med.nagoya-u.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
| 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
| 2022 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031270
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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