UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003121
Receipt number R000003781
Scientific Title A study about the method of the double balloon endoscopy: Comparison of single operator method and two operators method. A prospective study
Date of disclosure of the study information 2010/02/01
Last modified on 2012/01/19 19:40:18

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Basic information

Public title

A study about the method of the double balloon endoscopy: Comparison of single operator method and two operators method. A prospective study

Acronym

A study about the comparison of single operator method and two operators method. A prospective study

Scientific Title

A study about the method of the double balloon endoscopy: Comparison of single operator method and two operators method. A prospective study

Scientific Title:Acronym

A study about the comparison of single operator method and two operators method. A prospective study

Region

Japan


Condition

Condition

Digestive organs disease A pancreas biliary tract system disease

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

About utility of single operator method, we perform only retrpspective study. we understand no significant difference at region discovery rate, the frequency of the complication in Retrpspective study in all small intestine observation rate, observation time. On the other hand, I take 2 method in many institutions and show problems of one method, availability point and simplify inspection by promoting nobody method, and it is it with a merit to the that what I can introduce this inspection into easily in each institution is a small intestine mental change caused by a disease or large intestine endoscope difficulty.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

region discovery rate, the frequency of the complication, all small intestine observation rate, observation time.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

single operator method

Interventions/Control_2

single operator method

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

a patient who observed with balloon endoscopy

Key exclusion criteria

a patient who observed without balloon endoscopy

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiro Araki

Organization

Tokyo Medical and Dental University

Division name

Division of Endoscopy

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5877

Email



Public contact

Name of contact person

1st name
Middle name
Last name Akihiro Araki

Organization

Tokyo medical and Dental University

Division name

Gastroenterology and Hepatology

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

81-3-5803-5877

Homepage URL


Email

araki.gast@tmd.ac.jp


Sponsor or person

Institute

Department of Gastroenterology and Hepatology

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology and Hepatology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

東京医科歯科大学付属病院(東京都)


Other administrative information

Date of disclosure of the study information

2010 Year 02 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

Open public recruiting

Date of protocol fixation

2008 Year 05 Month 09 Day

Date of IRB


Anticipated trial start date

2008 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 02 Month 01 Day

Last modified on

2012 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003781


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name