UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008522 |
|---|---|
| Receipt number | R000010020 |
| Scientific Title | Evaluation of the predictive factors for the presence of small bowel ulcerative lesions and vascular lesions in patients with obscure gastrointestinal bleeding (OGIB): multicenter prospective study |
| Date of disclosure of the study information | 2012/07/24 |
| Last modified on | 2018/05/19 22:53:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the predictive factors for the presence of small bowel ulcerative lesions and vascular lesions in patients with obscure gastrointestinal bleeding (OGIB): multicenter prospective study
Acronym
The predictive factors for the presence of small bowel lesions in patients with OGIB
Scientific Title
Evaluation of the predictive factors for the presence of small bowel ulcerative lesions and vascular lesions in patients with obscure gastrointestinal bleeding (OGIB): multicenter prospective study
Scientific Title:Acronym
The predictive factors for the presence of small bowel lesions in patients with OGIB
Region
| Japan |
Condition
Condition
obscure gastrointestinal bleeding (OGIB)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect the predictive factors (including demographic and behavioral characteristics, comorbidity and medication use) for the presence of small bowel ulcerative lesions and vascular lesions in patients with OGIB
Basic objectives2
Others
Basic objectives -Others
To detect the predictive factors (including demographic and behavioral characteristics, comorbidity and medication use) for the presence of small bowel ulcerative lesions and vascular lesions in patients with OGIB
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency and numbers of small bowel ulcerative lesions and vascular lesions evaluated by capsule endoscopy
Key secondary outcomes
Capsule endoscopy score (Lewis score)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients with OGIB(patients had undergone gastrointestinal examinations recently, with negative findings)
2 Willingness to provide written informed consent.
Key exclusion criteria
1 Patients with implantable pacemaker
2 Patients judged as inappropriate candidates for the trial by the investigators
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Sakai |
Organization
Yokohama City University School of Medicine
Division name
Gastroenterology division
Zip code
Address
3-9, Fukuura Kanagawa-ku Yokohama Kanagawa
TEL
045-787-2800
eiji525@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Sakai |
Organization
Yokohama City University School of Medicine
Division name
Gastroenterology division
Zip code
Address
3-9, Fukuura Kanagawa-ku Yokohama Kanagawa
TEL
045-787-2800
Homepage URL
eiji525@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University 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
横浜市立大学医学部附属病院、横浜労災病院、茅ヶ崎市立病院、平塚市民病院、小田原市立病院、町田市民病院、都立広尾病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 24 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The frequency and numbers of small bowel ulcerative lesions and vascular lesions evaluated by capsule endoscopy
Management information
Registered date
| 2012 | Year | 07 | Month | 24 | Day |
Last modified on
| 2018 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010020
