UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficient surveillance of small bowel lesions in Crohn's disease
Title of the study (Brief title)	Efficient surveillance of small bowel lesions in Crohn's disease
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficient surveillance of the small bowel lesions in Crohn's disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of small bowel lesions in Crohn's disease by using capsule endoscopy
Key secondary outcomes

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	15 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Crohn's disease patients without intestinal stricture (2) Patients underwent per-anal balloon-assisted enteroscopy and the entire small intestine could not be observed
Key exclusion criteria	(1) Existing history or results of examination suggesting intestinal stricture (2) Anal stricture (3) Pregnant woman (4) Patients with pacemaker or ICD (5) Patients with swallowing disturbance (6) Patients with a history of hypersensitivity to barium sulfate
Target sample size	50

Research contact person
Name of lead principal investigator	Akira Andoh
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology
Address	Seta-Tsukinowa, Otsu
TEL	077-548-2217
Email	hqmed2@belle.shiga-med.ac.jp

Public contact
Name of contact person	Shigeki Bamba
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology
Address	Seta-Tsukinowa, Otsu
TEL	077-548-2217
Homepage URL
Email	sb@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Other
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	2016 Year 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 20 Day
Anticipated trial start date	2016 Year 06 Month 21 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	None

Management information
Registered date	2016 Year 06 Month 20 Day
Last modified on	2017 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026291