UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057968 |
|---|---|
| Receipt number | R000066274 |
| Scientific Title | A Validity Evaluation Study of Novel Endoscopic Treatment Simulators |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/26 16:24:20 |
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Basic information
Public title
A Validity Evaluation Study of Novel Endoscopic Treatment Simulators
Acronym
A Validity Evaluation Study of Novel Endoscopic Treatment Simulators
Scientific Title
A Validity Evaluation Study of Novel Endoscopic Treatment Simulators
Scientific Title:Acronym
A Validity Evaluation Study of Novel Endoscopic Treatment Simulators
Region
| Japan |
Condition
Condition
Early gastric cancer, Esophageal varices
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A novel model of gastric submucosal dissection and esophageal varices will be used to evaluate the clinical reproducibility and learning effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedure times will be measured and compared between expert and non-expert groups.
Key secondary outcomes
Evaluate the impact of simulator learning on knowledge, confidence, and expectations. Evaluate the characteristics of the simulator model by conducting a free-word analysis of the end of the questionnaire. Finally, we will evaluate the correlation between treatment success or failure and background factors in the expert and non-expert groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Treatment experience with novel simulator models. For experts.
Interventions/Control_2
Treatment experience with novel simulator models. For beginners.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study will include junior resident doctors, gastroenterology trainees, and attending physicians from Tohoku University Hospital. They need to agree to participate and provide informed consent before inclusion.
Key exclusion criteria
A person cannot consent to the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kanno |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
980-8574
Address
1-1,Seiryomachi Aoba-ku Sendai-shi Miyagi
TEL
022-717-7171
kanno.takeshi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Hatayama |
Organization
Tohoku University Hospital
Division name
Department of Gastroenterology
Zip code
980-8574
Address
1-1,Seiryomachi Aoba-ku Sendai-shi Miyagi
TEL
022-717-7171
Homepage URL
yutaka.hatayama.e4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2025 | Year | 06 | 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
| 2025 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will recruit learners.
Management information
Registered date
| 2025 | Year | 05 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066274
