UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015031 |
|---|---|
| Receipt number | R000017488 |
| Scientific Title | Analysis of Follow-up for Overt OGIB with Enteroscopically Negative Results - a prospective study - |
| Date of disclosure of the study information | 2014/09/02 |
| Last modified on | 2017/09/04 18:48:01 |
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Basic information
Public title
Analysis of Follow-up for Overt OGIB with Enteroscopically Negative Results - a prospective study -
Acronym
Follow-up for Overt OGIB with Enteroscopically Negative Results
Scientific Title
Analysis of Follow-up for Overt OGIB with Enteroscopically Negative Results - a prospective study -
Scientific Title:Acronym
Follow-up for Overt OGIB with Enteroscopically Negative Results
Region
| Japan |
Condition
Condition
Overt OGIB
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficient follow-up for Overt OGIB with Negative results of CE
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of re-bleeding wiyhin one year
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
CE at 3 months after bleeding
Interventions/Control_2
Observation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Overt OGIB with negative results of CE
Key exclusion criteria
physicians decision
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City
TEL
043-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City, JAPAN
TEL
043-226-2083
Homepage URL
araim-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba Network of Capusle Endoscopy
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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 02 | 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
| 2014 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2017 | 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
| 2014 | Year | 09 | Month | 02 | Day |
Last modified on
| 2017 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017488
| 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 |
