UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on digestive tract disease database centering on capsule endoscopy
Title of the study (Brief title)	Research on digestive tract disease database centering on capsule endoscopy
Region	Japan

Condition
Condition	Diseases associated with small bowel
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the capsule endoscope embodiment as a database and evaluate the effectiveness of examination / treatment, safety (accident), disease frequency, clinical picture and long-term prognosis (course)
Basic objectives2	Others
Basic objectives -Others	Establish academic evaluation in gastrointestinal disease.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Features of capsule endoscopic findings of each gastrointestinal disease
Key secondary outcomes	Clinical characteristics and treatment outcome of each gastrointestinal disease, long-term prognosis

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	10 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who sufficiently understood this research and gained consent
Key exclusion criteria	Patients who do not obtain consent to this study Patients who judged that other researchers are not appropriate as research subjects
Target sample size	1000

Research contact person
Name of lead principal investigator	Tnakanari Kitazono
Organization	Kyushu-University
Division name	Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5261
Email	akharada@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person	Akira Harada
Organization	Kyushu University
Division name	Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5261
Homepage URL
Email	akharada@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
Institute
Department

Funding Source
Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 18 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 24 Day
Anticipated trial start date	2017 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	registering now

Management information
Registered date	2017 Year 11 Month 18 Day
Last modified on	2018 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034289