UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057205 |
|---|---|
| Receipt number | R000065386 |
| Scientific Title | A prospective study on endoscopic treatment training model using familiar materials |
| Date of disclosure of the study information | 2025/03/10 |
| Last modified on | 2025/03/04 17:06:55 |
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Basic information
Public title
A prospective study on endoscopic treatment training model using familiar materials
Acronym
A prospective study on endoscopic treatment training model using familiar materials
Scientific Title
A prospective study on endoscopic treatment training model using familiar materials
Scientific Title:Acronym
A prospective study on endoscopic treatment training model using familiar materials
Region
| Japan |
Condition
Condition
Digestive disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify what differences are observed between novices and experts when endoscopists utilize Dry model and Paper bowl kit
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following items in DM and PBK
1. Accuracy of the wavy line model in PBK
2. Time required to complete the wavy line model inPBK
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who completed the practice with the Paper Bowl Kit during the study period
Key exclusion criteria
1) Cases in which accurate results could not be obtained due to missing data or equipment problems.
2) Cases in which the consent form for participating in the study was revoked.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | daizen |
| Middle name | |
| Last name | hirata |
Organization
Sano Hospital
Division name
Gastrointestinal Center
Zip code
6550031
Address
2-5-1,shimizugaoka, tarumiku,koubeshi
TEL
0787851000
yonedarieko@gmail.com
Public contact
Name of contact person
| 1st name | sachiko |
| Middle name | |
| Last name | shimizu |
Organization
Sano Hospital
Division name
Gastrointestinal Center
Zip code
6550031
Address
2-5-1,shimizugaoka, tarumiku,koubeshi
TEL
0787851000
Homepage URL
murasachi1004@gmail.com
Sponsor or person
Institute
Sano Hospital
Institute
Department
Personal name
Funding Source
Organization
Sano Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sano Hospital
Address
2-5-1,shimizugaoka, tarumiku,koubeshi
Tel
0787851000
yonedarieko@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 10 | 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 | 02 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
The study will be conducted as part of the training course for endoscopists at the Gastroenterology Centre, Sano Hospital.
Management information
Registered date
| 2025 | Year | 03 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065386
