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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046671
Receipt No. 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

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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
Email 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
Email kenzou.hara@med.toho-u.ac.jp

Sponsor
Institute Toho University Omori Medical Center
Division of Gastroenterology and hepatology
Institute
Department

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
Email 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
URL(English) 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
Registered date File name


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