UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017835
Receipt number R000020664
Scientific Title The assessment of insertion improvement by ultra-small caliber single balloon endoscope in difficult cases
Date of disclosure of the study information 2015/06/08
Last modified on 2015/06/09 08:04:15

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Basic information

Public title

The assessment of insertion improvement by ultra-small caliber single balloon endoscope in difficult cases

Acronym

ultra-small caliber SBE

Scientific Title

The assessment of insertion improvement by ultra-small caliber single balloon endoscope in difficult cases

Scientific Title:Acronym

ultra-small caliber SBE

Region

Japan


Condition

Condition

difficult insertion cases by standard SBE

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Improvement of endoscopic insertion

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Insertion improvement changing from standard SBE(SIF-Q260) to ultra-small caliber SBE(SIF-Y0006)

Key secondary outcomes

safety, insertion time and length of both SBE


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

change to SIF-Y0006 scope

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

The insertion length below 1m using SIF-Q260

Key exclusion criteria

In case of the deeper insertion is considered as dageourous or not perferable

In casde of not preferable using SIF-Y0006

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yutaka Endo

Organization

OFUNA CHUO HOSPITAL

Division name

G.I./IBD center

Zip code


Address

6-2-24 Ofuna, Kamakura, kanagawa, Japan

TEL

0467-45-2111

Email

yutaka-endo@ofunachuohp.net


Public contact

Name of contact person

1st name
Middle name
Last name Yutaka Endo

Organization

OFUNA CHUO HOSPITAL

Division name

G.I./IBD center

Zip code


Address

6-2-24 Ofuna, Kamakura, kanagawa, Japan

TEL

0467-45-2111

Homepage URL


Email

yutaka-endo@ofunachuohp.net


Sponsor or person

Institute

GI/IBD center, Ofuna Chou hospital

Institute

Department

Personal name



Funding Source

Organization

olympus company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Endoscopy University Hospital of Medicine Tokyo Medical and Dental University

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

2015 Year 06 Month 08 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

2015 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 08 Day

Last follow-up date

2016 Year 05 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 06 Month 08 Day

Last modified on

2015 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020664


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name