UMIN-CTR Clinical Trial

Basic information
Public title	Surveillance of intestinal lesions in patients taking new oral anticoagulant drugs
Acronym	Intestinal lesions by new oral anticoagulant drugs
Scientific Title	Surveillance of intestinal lesions in patients taking new oral anticoagulant drugs
Scientific Title:Acronym	Intestinal lesions by new oral anticoagulant drugs
Region	Japan

Condition
Condition	Surveillance of intestinal lesions in patients taking new oral anticoagulant drugs
Classification by specialty	Medicine in general Gastroenterology Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine intestinal lesions using capsule endoscopy in patients taking new oral anticoagulant drugs
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intestinal lesions
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	capsule endoscopy
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients taking new oral anticoagulant drugs
Key exclusion criteria	stenosis of GI tract
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Imaeda
Organization	Saitama Medical School
Division name	Department of General Internal Medicine
Zip code
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL	049-276-1667
Email	imaedahi@saitama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Imaeda
Organization	Saitama Medical School
Division name	Department of General Internal Medicine
Zip code
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL	049-276-1667
Homepage URL
Email	imaedahi@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical School
Institute
Department

Funding Source
Organization	Saitama Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Keio University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	埼玉医科大学、慶應義塾大学

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 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	2013 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date	2013 Year 10 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

Management information
Registered date	2013 Year 08 Month 20 Day
Last modified on	2017 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013486

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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