UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046671 |
|---|---|
| Receipt number | R000053244 |
| Scientific Title | Effectiveness for the shorting of hemostatic time using RDI on bleeding by biopsy forcep |
| Date of disclosure of the study information | 2022/01/19 |
| Last modified on | 2022/01/19 14:50:32 |
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Basic information
Public title
Effectiveness for the shorting of hemostatic time using RDI on bleeding by biopsy forceps
Acronym
RDI-hara study
Scientific Title
Effectiveness for the shorting of hemostatic time using RDI on bleeding by biopsy forcep
Scientific Title:Acronym
RDI-hara study
Region
| Japan |
Condition
Condition
ulcerlative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness for the shorting of hemostatic time using RDI on bleeding by biopsy forceps
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
shorting of hemostatic time using RDI during colonoscopy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
RDIInterventions: RDI
Interventions/Control_2
Control: WLI
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. age:20-80year old, male or female, remission of ulcerlative colitis
2. taking 5-ASA
3. blood examination:hemoglobin more than 8.0g/dL and Platet more than 100000/mm3
4. informed consent
Key exclusion criteria
1. Not remission phase of ulcerlative colitis
2. performed endoscopic hemostasis due to no spontaneous hemostasis
3. takign biopsy from several locations of colon
4. history of taking steroid and/or immunosuppresion medicine and/or biopharmarcy and/or G-CAP
5. no cessation of antithrombotic drugs
6. hemodialysis
7. no take an informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | KENZO |
| Middle name | |
| Last name | HARA |
Organization
Toho University Omori Medical Center
Division name
Division of Gastroenterology and hepatology
Zip code
143-8541
Address
6-11-1 Omorinishi Ota-ku Tokyo Japan
TEL
03-3762-4151
kenzou.hara@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | kenzo |
| Middle name | |
| Last name | hara |
Organization
Toho University Omori Medical Center
Division name
Division of Gastroenterology and hepatology
Zip code
143-8541
Address
6-11-1 Omorinishi Ota-ku Tokyo Japan
TEL
03-3762-4151
Homepage URL
kenzou.hara@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Division of Gastroenterology and hepatology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Omori Medical Center
Address
Division of Gastroenterology and hepatology
Tel
03-3762-4151
kenzou.hara@med.toho-u.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
| 2022 | Year | 01 | Month | 19 | 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
| 2022 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 01 | Month | 19 | Day |
Last modified on
| 2022 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053244
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
