UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020609
Receipt number R000023686
Scientific Title The prospective study for diagnosing small bowel stenosis using small bowel endoscopy via oral route
Date of disclosure of the study information 2016/03/01
Last modified on 2021/05/10 09:12:32

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023686