UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Eiji Sakai
Organization	Yokohama City University School of Medicine
Division name	Gastroenterology division
Address	3-9, Fukuura Kanagawa-ku Yokohama Kanagawa
TEL	045-787-2800
Email	eiji525@yokohama-cu.ac.jp

Public contact
Name of contact person	Eiji Sakai
Organization	Yokohama City University School of Medicine
Division name	Gastroenterology division
Address	3-9, Fukuura Kanagawa-ku Yokohama Kanagawa
TEL	045-787-2800
Homepage URL
Email	eiji525@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010020