UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of capsule endoscopy and double-balloon enteroscopy for small-bowel diseases
Title of the study (Brief title)	Capsule endoscopy and double-balloon enteroscopy
Region	Japan

Condition
Condition	Small-bowel diseases
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the usefulness and the adverse events of capsule endoscopy and double-balloon enteroscopy retrospectively and prospectively for small-bowel diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Usefulnessof capsule endoscopy and double-balloon enteroscopy
Key secondary outcomes	Adverse events of capsule endoscopy and double-balloon enteroscopy

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	Patients with documented or suspected small-bowel diseases
Key exclusion criteria	Patients without indications of double-balloon enteroscopy and capsule endoscopy.
Target sample size	1500

Research contact person
Name of lead principal investigator	Naoki Ohmiya
Organization	Fujita Health University
Division name	Department of Gastroenterology
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192
TEL	0562-93-9240
Email	nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person	Naoki Ohmiya
Organization	Fujita Health University
Division name	Department of Gastroenterology
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192
TEL	0562-93-9240
Homepage URL
Email	nohmiya@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
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	藤田保健衛生大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 03 Month 31 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 01 Month 10 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Diagnostic yields of double-balloon enteroscopy and capsule endoscopy
Other related information	Adverse events of double-balloon enteroscopy and capsule endoscopy

Management information
Registered date	2017 Year 07 Month 17 Day
Last modified on	2017 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032345