UMIN-CTR Clinical Trial

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
Email	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
Email	toki_saito@m.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051634