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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020625
Receipt No. R000023805
Scientific Title Use of the new supraglottic device Ambu AuraGain in clinical settings
Date of disclosure of the study information 2016/01/19
Last modified on 2016/02/15

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Basic information
Public title Use of the new supraglottic device Ambu AuraGain in clinical settings
Acronym Use of the AuraGain in clinical settings
Scientific Title Use of the new supraglottic device Ambu AuraGain in clinical settings
Scientific Title:Acronym Use of the AuraGain in clinical settings
Region
Japan

Condition
Condition the cases inserted the new supraglottic device Ambu AuraGain
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 a use investigation of the AuraGain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the number of insertion
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 the cases inserted the AuraGain
Key exclusion criteria the cases not inserted the AuraGain
Target sample size

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Ueshimaironobu
Organization Showa University Hospital
Division name Anesthesiology
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo Japan
TEL 03-3784-8575
Email ueshimhi@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironobu Ueshima
Organization Showa University Hospital
Division name Anesthesiology
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan-ku
TEL 03-3784-8575
Homepage URL
Email ueshimhi@yahoo.co.jp

Sponsor
Institute Showa University Hospital
Institute
Department

Funding Source
Organization Showa University Hospital
Organization
Division
Category of Funding Organization Other
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 01 Month 19 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 19 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information the cases inserted the AuraGain November 2015 to December 2015
Patient data was collected, including age, gender, body mass index, American society of Anesthesiologist classification, Mallampati classification, size of the AuraGain, the number of insertion and the size of gastric tube inserted after the insertion of AuraGain.

Management information
Registered date
2016 Year 01 Month 19 Day
Last modified on
2016 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=R000023805

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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