UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045221 |
|---|---|
| Receipt number | R000051634 |
| Scientific Title | Development of a self-training system for open surgery using Augmented Reality(AR) |
| Date of disclosure of the study information | 2021/08/24 |
| Last modified on | 2022/08/31 14:05:58 |
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Basic information
Public title
Development of a self-training system for open surgery using Augmented Reality(AR)
Acronym
Development of a self-training system for open surgery using Augmented Reality(AR)
Scientific Title
Development of a self-training system for open surgery using Augmented Reality(AR)
Scientific Title:Acronym
Development of a self-training system for open surgery using Augmented Reality(AR)
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of a new self-training system for open surgery using Augmented Reality
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedures are video recorded before and after self-training using systems, and scored by expert surgeons.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Participants practice sutures ten times using the AR system.
Interventions/Control_2
Participants practice sutures ten times watching videos.
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
Medical students in the University of Tokyo who don't have any disease which may affect the experiment.
Key exclusion criteria
Participants who interrupted the experiment in any reason.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Oyama |
Organization
The University of Tokyo
Division name
Department of Clinical Information Engineering, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo
TEL
03-5841-1893
hoyama@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Toki |
| Middle name | |
| Last name | Saito |
Organization
The University of Tokyo
Division name
Department of Clinical Information Engineering, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo
TEL
03-5841-1893
Homepage URL
toki_saito@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Graduate School of Medicine, ethics committee
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo
Tel
03-5841-1893
ethics@m.u-tokyo.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
| 2021 | Year | 08 | Month | 24 | 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
43
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
Main results already published
Date of protocol fixation
| 2021 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 22 | Day |
Last modified on
| 2022 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051634
