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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013145
Receipt No. R000015326
Scientific Title Time shortening of trans nasal endoscopy examination using air supply device
Date of disclosure of the study information 2014/02/13
Last modified on 2018/02/15

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Basic information
Public title Time shortening of trans nasal endoscopy examination using air supply device
Acronym trans nasal endoscopy and air supply device
Scientific Title Time shortening of trans nasal endoscopy examination using air supply device
Scientific Title:Acronym trans nasal endoscopy and air supply device
Region
Japan

Condition
Condition Upper gastrointestinal disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of time shortening at gastric dilatation using water supply device AF-WP1 as an air supply device.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes gastric dilatation time
Key secondary outcomes

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 Additional use of water supply device AF-WP1 as an air supply device
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 The patients who are going to have trans nasal endoscopy examination.
Key exclusion criteria The patients who are not suitable to have trans nasal endoscopy examination.
The patients who do not agree to enter this trial.
In addition, the patients whose physician consider inadequate.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Suzuki
Organization University of Tsukuba
Division name Center of planning and coordination for medical education
Zip code
Address 1-1-1 tennnodai,tsukuba,ibaraki
TEL 0298-53-3218
Email hideoszk@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Suzuki
Organization University of Tsukuba
Division name Center of planning and coordination for medical education
Zip code
Address 1-1-1 tennnodai,tsukuba,ibaraki
TEL 0298-53-3218
Homepage URL
Email hideoszk@md.tsukuba.ac.jp

Sponsor
Institute Division of endoscopy
Institute
Department

Funding Source
Organization Division of endoscopy
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 筑波大学附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 13 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
2014 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 13 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
2014 Year 02 Month 12 Day
Last modified on
2018 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015326

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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