UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057817 |
|---|---|
| Receipt number | R000066079 |
| Scientific Title | A Study on the Clinical Validity of a Colonic Diverticular Bleeding Simulator Model |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/26 18:11:57 |
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Basic information
Public title
A Study on the Clinical Validity of a Colonic Diverticular Bleeding Simulator Model
Acronym
A Study on the Clinical Validity of a Colonic Diverticular Bleeding Simulator Model
Scientific Title
A Study on the Clinical Validity of a Colonic Diverticular Bleeding Simulator Model
Scientific Title:Acronym
A Study on the Clinical Validity of a Colonic Diverticular Bleeding Simulator Model
Region
| Japan |
Condition
Condition
Colonic diverticular bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the developed colonic diverticular bleeding model properly reflects actual clinical performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Compare the hemostasis treatment time for diverticular bleeding using endoscopic band ligation (EBL) between the expert group and the non-expert group.
(2) Compare the hemostasis treatment time using conventional air insufflation (CAI) and gel immersion endoscopy (GIE) in the non-expert group.
Key secondary outcomes
1) Compare the treatment times of CAI and GIE among the expert group.
2) Evaluate the effects of simulator training using a model on knowledge, confidence, and expectations through a questionnaire.
3) Evaluate the correlation between treatment success/failure and background factors in the expert group and non-expert group.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
After allocation with computer randomization, perform EBL hemostasis in the order of the conventional method with air inflation followed by gel immersion endoscopy.
Interventions/Control_2
After allocation with computer randomization, perform EBL hemostasis in the order of gel immersion endoscopy, followed by the conventional method with air inflation.
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 residents, gastroenterology fellows, and attending physicians working at Tohoku University Hospital who provide informed consent to participate.
Key exclusion criteria
Individuals who do not meet the inclusion criteria or who do not provide informed consent will be excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kannno |
Organization
Tohoku University Graduate School of Medicine
Division name
Division 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 | Kanako |
| Middle name | |
| Last name | Ogasawara |
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
Homepage URL
kanako.ogasawara.c3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Denka Company Limited,U-A Corporation
Name of secondary funder(s)
Denka Company Limited
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 | 02 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 05 | Month | 09 | 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=R000066079
