UMIN-CTR Clinical Trial

Basic information
Public title	Prototype single-balloon enteroscopy with passive-bending and high force transmission insertion tube improves depth of insertion in the small intestine.
Acronym	Prototype single-balloon enteroscopy and insertability in stricturing CD
Scientific Title	Prototype single-balloon enteroscopy with passive-bending and high force transmission insertion tube improves depth of insertion in the small intestine.
Scientific Title:Acronym	Prototype single-balloon enteroscopy and insertability in stricturing CD
Region	Japan

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

Objectives
Narrative objectives1	To clarify the efficacy of EBD using single-balloon enteroscopy for small intestinal strictures of CD. We also clarify the factors contributing to surgery and the effectiveness of the passive bending mechanism in EBD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Cumulative surgery free rate
Key secondary outcomes	Factors that contribute to surgery The insertability of a prototype single balloon enteroscope (SBE)

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	CD patients who underwent EBD for small intestinal stricture lesions from October 2005 to December 2018 at Shiga University of medical science.
Key exclusion criteria	Patients without EBD for small bowel lesions (eg, cases with EBD only for gastric lesions and large intestine lesions). Patients who could not track after EBD. Patient using double balloon small intestine enteroscopy for EBD.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Andoh
Organization	Shiga university of medical science
Division name	Gastroenterology
Zip code	520-2192
Address	Tukinowa Seta Otu-shi Shiga-ken Jpan
TEL	077-548-2111
Email	hqmed2@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Shigeki Middle name Last name Bamba
Organization	Shiga university of medical science
Division name	Clinical nutrition
Zip code	520-2192
Address	Tukinowa Seta Otu-shi Shiga-ken Jpan
TEL	077-548-2111
Homepage URL
Email	hqmed2@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga university of medical science
Institute
Department

Funding Source
Organization	Self funding
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	Shiga university of medical science
Address	Tukinowa Seta Otu-shi Shiga-ken Jpan
Tel	077-548-3576
Email	hqrec@belle.shiga-med.ac.jp

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	2019 Year 06 Month 20 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	Preinitiation
Date of protocol fixation	2019 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date	2019 Year 06 Month 20 Day
Last follow-up date	2020 Year 12 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a retrospective study. This study is a verification study to clarify the effectiveness of EBD. The type of study is a past cohort study.

Management information
Registered date	2019 Year 06 Month 18 Day
Last modified on	2019 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042270