UMIN-CTR Clinical Trial

Basic information
Public title	Tolerability evaluation of newly ultrathin double-balloon endoscopy for the diagnosis and treatment of small bowel diseases: Multicenter prospective study
Acronym	Clinical utility of newly double-balloon enteroscope
Scientific Title	Tolerability evaluation of newly ultrathin double-balloon endoscopy for the diagnosis and treatment of small bowel diseases: Multicenter prospective study
Scientific Title:Acronym	Clinical utility of newly double-balloon enteroscope
Region	Japan

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

Objectives
Narrative objectives1	to evaluate the tolerability of newly double-balloon endoscopy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	difference of serum amylase level between before and after procedure
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	1age: 20 or more than 20 years old 2obtained informed consent 3oral route of double-balloon endoscopy planned for the suspected small bowel diseases
Key exclusion criteria	1)Patients with acute abdomen 2)Patients with severe acute inflammation 3)pregnant patients 4)Patients in a very bad general condition 5)Patients having severe blood clotting defect 6Patients who have participated in same clinical trials. 7Patients, the investigator (or the subinvestigator) considers, inappropriate for entry into the trial.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidemi Goto
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	65, Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2164
Email	hgoto@med.nagoya-u.ac.jp

Public contact
Name of contact person	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
Homepage URL
Email	makamura@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine, 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)

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	自治医科大学消化器内科 (栃木県） 日本医科大学付属病院消化器内科（東京都） 広島大学病院内視鏡診療科（広島県） 福岡大学筑紫病院消化器内科 （福岡県） 九州大学大学院医学研究科病態機能内科学（福岡県） 岩手医科大学消化器内科　（岩手県）

Other administrative information
Date of disclosure of the study information	2015 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	2015 Year 01 Month 29 Day
Date of IRB	2015 Year 01 Month 30 Day
Anticipated trial start date	2015 Year 07 Month 21 Day
Last follow-up date	2021 Year 01 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2014 Year 12 Month 03 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=R000018428