UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007104 |
|---|---|
| Receipt number | R000008360 |
| Scientific Title | Findings related to the endoscopic and other diagnostic procedures in gastrointestinal hemorrhage |
| Date of disclosure of the study information | 2012/01/19 |
| Last modified on | 2012/01/19 20:04:25 |
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Basic information
Public title
Findings related to the endoscopic and other diagnostic procedures in gastrointestinal hemorrhage
Acronym
Evidence of gastrointestinal bleeding
Scientific Title
Findings related to the endoscopic and other diagnostic procedures in gastrointestinal hemorrhage
Scientific Title:Acronym
Evidence of gastrointestinal bleeding
Region
| Japan |
Condition
Condition
gastrointestinal bleeding
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Gastrointestinal surgery | Radiology | Laboratory medicine |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the association of various assays for gastrointestinal bleeding
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Stool occult blood hemoglobin capsule endoscopy Double balloon endoscopy EGD colonoscopy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with signs of gastrointestinal bleeding
Key exclusion criteria
Children under 20 years
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Araki |
Organization
Tokyo Medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
81-3-5803-5877
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Araki |
Organization
Tokyo medical and Dental University
Division name
Gastroenterology and Hepatology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
81-3-5803-5877
Homepage URL
araki.gast@tmd.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京医科歯科大学付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will check each of the data at the onset of gastrointestinal bleeding
Management information
Registered date
| 2012 | Year | 01 | Month | 19 | Day |
Last modified on
| 2012 | 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=R000008360
