UMIN-CTR Clinical Trial

Basic information
Public title	The prospective study for diagnosing small bowel stenosis using small bowel endoscopy via oral route
Acronym	The prospective diagnostic study using small bowel endoscopy
Scientific Title	The prospective study for diagnosing small bowel stenosis using small bowel endoscopy via oral route
Scientific Title:Acronym	The prospective diagnostic study using small bowel endoscopy
Region	Japan

Condition
Condition	small bowel stenosis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	diagnostic yield for small bowel stenosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	diagnostic yield for small bowel stenosis
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. 20 years old or more 2. getting written consent form 3. scheduled oral small bowel endoscopy for diagnosing small bowel stenosis
Key exclusion criteria	A) severe inflammation is complicated. B) Pregnancy C) Poor general condition D) having severe baseline disease for heart, lung, kidney, or liver. E) bradycardia or A-V block on ECG F) previously parpicipated in this study G) Doctor's decision
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masanao Nakamura
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	65, Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2172
Email	makamura@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takeshi Yamamura
Organization	Nagoya University Hospital
Division name	Department of Endoscopy
Zip code
Address	65, Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2172
Homepage URL
Email	makamura@med.nagoya-u.ac.jp

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

Funding Source
Organization	Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 03 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	2016 Year 01 Month 09 Day
Date of IRB	2016 Year 05 Month 24 Day
Anticipated trial start date	2016 Year 05 Month 24 Day
Last follow-up date	2021 Year 03 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a prospective and observation study to check the clinical diagnosis using small bowel endoscopy

Management information
Registered date	2016 Year 01 Month 18 Day
Last modified on	2021 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023686