UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020625 |
|---|---|
| Receipt number | 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 19:00:38 |
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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
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
ueshimhi@yahoo.co.jp
Sponsor or person
Institute
Showa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023805
