UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050708 |
|---|---|
| Receipt number | R000057637 |
| Scientific Title | A single-blind randomized controlled trial to evaluate the effectiveness of an educational program using the novel bleeding ulcer model |
| Date of disclosure of the study information | 2023/03/30 |
| Last modified on | 2024/09/28 10:56:28 |
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Basic information
Public title
A single-blind randomized controlled trial to evaluate the effectiveness of an educational program using the novel bleeding ulcer model
Acronym
A single-blind randomized controlled trial to evaluate the effectiveness of an educational program using the novel bleeding ulcer model
Scientific Title
A single-blind randomized controlled trial to evaluate the effectiveness of an educational program using the novel bleeding ulcer model
Scientific Title:Acronym
A single-blind randomized controlled trial to evaluate the effectiveness of an educational program using the novel bleeding ulcer model
Region
| Japan |
Condition
Condition
Hemorrhagic ulcer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness of an educational intervention using the bleeding ulcer model in endoscopic hemostasis with hemostatic forceps.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the learning effects of the learning program between the two groups with and without intervention in an evaluation by blinded experts.
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
No treatment
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
Conduct a learning program on endoscopic hemostasis using the bleeding ulcer model.
Interventions/Control_2
No education
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Physicians and residents of gastroenterology
Key exclusion criteria
Those who did not give their consent.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Koike |
Organization
Tohoku University
Division name
Division of gastoroenterology
Zip code
980-8575
Address
2-1, Seiryocho, Aobaku, Sendai-shi, Miyagi
TEL
022-717-8009
suguo.0417@gmail.com
Public contact
Name of contact person
| 1st name | Suguo |
| Middle name | |
| Last name | Suzuki |
Organization
Graduate school of medicine
Division name
Division of gastoroenterology
Zip code
980-8575
Address
2-1, Seiryocho, Aobaku, Sendai-shi, Miyagi
TEL
022-717-8009
Homepage URL
suguo.0417@gmail.com
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
| 2023 | Year | 03 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are currently 56 sessions into my goal of 130 training sessions.
Management information
Registered date
| 2023 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057637
