UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060399 |
|---|---|
| Receipt number | R000069092 |
| Scientific Title | Mixed Reality-Based Education Using a Three-Dimensional Anatomical Model For Pancreatobiliary Endoscopic Procedures: A Multicenter Study |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2026/01/18 14:22:15 |
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Basic information
Public title
Mixed Reality-Based Education Using a Three-Dimensional Anatomical Model For Pancreatobiliary Endoscopic Procedures: A Multicenter Study
Acronym
Mixed Reality-Based Education Using a Three-Dimensional Anatomical Model For Pancreatobiliary Endoscopic Procedures
Scientific Title
Mixed Reality-Based Education Using a Three-Dimensional Anatomical Model For Pancreatobiliary Endoscopic Procedures: A Multicenter Study
Scientific Title:Acronym
Mixed Reality-Based Education Using a Three-Dimensional Anatomical Model For Pancreatobiliary Endoscopic Procedures
Region
| Japan |
Condition
Condition
biliary stricture, pancreatic duct stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the usefulness of education on ERCP-related procedures using three-dimensional (3D) models within mixed reality (MR), including its applicability to remote education.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre and post education changes in trainees' scores assessing (1) comprehension of three-dimensional anatomical structures and (2) ability to develop procedural strategies using three-dimensional (3D) models in mixed reality (MR).
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
| Device,equipment |
Interventions/Control_1
Participants receive pre-procedural training using three-dimensional (3D) models within mixed reality (MR).
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who undergo ERCP-related procedures after receiving pre-procedural education using three-dimensional (3D) models in mixed reality (MR) between the date of IRB approval for this clinical study and March 31, 2029.
Key exclusion criteria
(1) Withdrawal of consent by the participant.
(2) Any other case deemed unsuitable for participation by the principal investigator or subinvestigator.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Tanisaka |
Organization
Saitama Medical University International Medical Center
Division name
Gastroenterology
Zip code
3501298
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
0429844111
tanisaka1205@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Tanisaka |
Organization
Saitama Medical University International Medical Center
Division name
Gastroenterology
Zip code
3501298
Address
1397-1, Yamane, Hidaka, Saitama 350-1298, Japan
TEL
0429844111
Homepage URL
tanisaka1205@gmail.com
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
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
Saitama Medical University International Medical Center
Address
1397-1, Yamane, Hidaka, Saitama, JAPAN
Tel
0429844111
tanisaka1205@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Not required for this country
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 19 | 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 | 01 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | 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 | 01 | Month | 18 | Day |
Last modified on
| 2026 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069092
