UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055901 |
|---|---|
| Receipt number | R000062914 |
| Scientific Title | Usefulness of a training program with endoscopic hemostasis simulator for trainees of gastrointestinal endoscopy |
| Date of disclosure of the study information | 2024/10/22 |
| Last modified on | 2024/10/22 11:13:51 |
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Basic information
Public title
Usefulness of a training program with endoscopic hemostasis simulator
Acronym
Innovative simulator for endoscopic hemostasis
Scientific Title
Usefulness of a training program with endoscopic hemostasis simulator for trainees of gastrointestinal endoscopy
Scientific Title:Acronym
Innovative Simulator for Endoscopic Hemostasis (ISEH)
Region
| Japan |
Condition
Condition
hemorrhagic ulcer of the stomach
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether a training program with an original simulator of endoscopic hemostasis for bleeding gastric ulcer is effective for trainees at local base hospitals
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To establish a learning curve of total time for endoscopic hemostasis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Training Program for endoscopic hemostasis in local base hospital
Interventions/Control_2
Training Program for endoscopic hemostasis in university hospital
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
| 24 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Trainees of gastrointestinal endoscopy in local base hospitals and a university hospital
Key exclusion criteria
1. unwillingness for this training program
2. inappropriate for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kaname |
| Middle name | |
| Last name | Uno |
Organization
Tohoku University
Division name
Division of Promotion for Gastroenterological Medical Innovation
Zip code
9818574
Address
1-1 Seiryo-cho Aoba-ku Sendai Miyagi Japan
TEL
81227177171
kaname.uno.c3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kaname |
| Middle name | |
| Last name | Uno |
Organization
Tohoku University
Division name
Division of Promotion for Gastroenterological Medical Innovation
Zip code
9818574
Address
1-1 Seiryo-cho Aoba-ku Sendai Miyagi Japan
TEL
81227177171
Homepage URL
kaname.uno.c3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University, Graduate School of Medicine, Division of Promotion for Gastroenterological Medical Innovation
Institute
Department
Personal name
Funding Source
Organization
Towada City Central Hospital
Organization
Division
Category of Funding Organization
Local Government
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-cho Aoba-ku Miyagi Japan
Tel
81227284105
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
| 2024 | Year | 10 | Month | 22 | 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
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062914
