UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of the usefulness and the adverse events in the extended evaluation methods of patency capsule
Title of the study (Brief title)	A prospective study about patency capsule
Region	Japan

Condition
Condition	The patients with established Crohn's disease and the other established or suspected small bowel disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The evaluation of patency capsule for patients with established Crohn's disease and the other small bowel disease who undergo capsule endoscopy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	retention rate of capsule endoscopy
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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	long time observation of patency capsule
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with established Crohn&#39;s disease and the other established or suspected small bowel disease
Key exclusion criteria	1: Patients with established retention or impaction of capsule endoscopy by the other examinations for small bowel 2: No bowel movements for over 4 days 3: Abdominal operated patients with difficulty to confirm safety to perform this investigation with the other examinations for small bowel 4: Subjects with pacemakers or other implanted electromedical devices 5: Swallowing disorder 6: Pregnant women 7: Patients with difficulty to perform the prescribed examinations 8: A serious patient 9: The patient who the physician judged as inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	Hidemi Goto
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	65, Tsuruma-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	052-744-2172
Email	hgotoa@med.nagoya-u.ac.jp

Public contact
Name of contact person	Masanao Nakamura
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	65, Tsuruma-cho, Showa-ku, Nagoya, Aichi
TEL	052-744-2172
Homepage URL
Email	makamura@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Nagoya University Graduate 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

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 15 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

Management information
Registered date	2013 Year 04 Month 09 Day
Last modified on	2017 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011721