UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062580 |
|---|---|
| Receipt number | R000071618 |
| Scientific Title | Development of a New Surgical Airway Management Simulator Utilizing Mixed Reality Technology |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/14 17:02:27 |
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Basic information
Public title
Development of a New Surgical Airway Management Simulator Utilizing Mixed Reality Technology
Acronym
Development of a Mixed Reality Surgical Airway Management Simulator
Scientific Title
Development of a New Surgical Airway Management Simulator Utilizing Mixed Reality Technology
Scientific Title:Acronym
Development of a Mixed Reality Surgical Airway Management Simulator
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we developed a new simulator application using the Meta Quest 3-a head-mounted MR device manufactured by Meta-and evaluated its educational effectiveness and utility, while also demonstrating its ease of use, cost-effectiveness, and practicality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective evaluation was conducted via questionnaires.
Objective evaluation assessed the level of procedural proficiency through practical exercises using models.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Surgical Airway Management Training Using Mixed Reality Head-mounted display
Interventions/Control_2
Control group
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals with little or no experience in establishing a surgical airway, such as medical students or dentists involved in clinical research.
Individuals who have provided consent to participate in this study.
Individuals capable of completing the questionnaire.
Key exclusion criteria
Individuals who have requested not to participate in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Sasaki |
Organization
Sapporo Medical University
Division name
Department of Oral Surgery
Zip code
060-8556
Address
17, Minami-1-jonishi, Chuo-ku, Sapporo-shi
TEL
011-611-2111
sasaki.takanori@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Sasaki |
Organization
Sapporo Medical University
Division name
Department of Oral Surgery
Zip code
060-8556
Address
17, Minami-1-jonishi, Chuo-ku, Sapporo-shi
TEL
011-611-2111
Homepage URL
sasaki.takanori@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
17, Minami-1-jonishi, Chuo-ku, Sapporo-shi
Tel
011-611-2111
irb_info@sapmed.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
| 2026 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 14 | Day |
Last modified on
| 2026 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071618
