UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022995 |
|---|---|
| Receipt number | R000026505 |
| Scientific Title | A prospective validation study for the Obscure Gastrointestinal Bleeding Score to predict the usefulness of double-balloon endoscopy in patients with obscure gastrointestinal bleeding. |
| Date of disclosure of the study information | 2016/07/31 |
| Last modified on | 2016/10/25 00:18:29 |
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Basic information
Public title
A prospective validation study for the Obscure Gastrointestinal Bleeding Score to predict the usefulness of double-balloon endoscopy in patients with obscure gastrointestinal bleeding.
Acronym
A prospective validation study for the Obscure Gastrointestinal Bleeding Score to predict the usefulness of double-balloon endoscopy in patients with obscure gastrointestinal bleeding.
Scientific Title
A prospective validation study for the Obscure Gastrointestinal Bleeding Score to predict the usefulness of double-balloon endoscopy in patients with obscure gastrointestinal bleeding.
Scientific Title:Acronym
A prospective validation study for the Obscure Gastrointestinal Bleeding Score to predict the usefulness of double-balloon endoscopy in patients with obscure gastrointestinal bleeding.
Region
| Japan |
Condition
Condition
Obscure gastrointestinal bleeding
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to build a new simple numerical scoring system that predicts who among patients with OGIB requires DBE on the basis of clinical profiles, laboratory findings, and CE findings,and to validate its usefulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of OGIB score
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Full written informed consent is obtained from each patient.
2.Patients who are diagnosed as OGIB that is defined as overt bleeding or recurrent
fecal occult bleeding with anemia of unknown origin at either conventional EGD or colonoscopy and who underwent capsule endoscopy.
Key exclusion criteria
1.Patients who are pregnant.
2.Patients with severe general condition.
3.Patients who had already been enrolled in this study.
4.Patients judged as inappropriate candidates for the trial by the investigators
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanao Nakamura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya Aichi
TEL
052-744-2180
makamura@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanao Nakamura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya Aichi
TEL
052-744-2180
Homepage URL
makamura@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 07 | Month | 31 | 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
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective and observation study to validate the Obscure Gastrointestinal Bleeding Score to predict the usefulness of double-balloon endoscopy in patients with obscure gastrointestinal bleeding.
Management information
Registered date
| 2016 | Year | 07 | Month | 03 | Day |
Last modified on
| 2016 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026505
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
