UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031078 |
|---|---|
| Receipt number | R000035485 |
| Scientific Title | Investigation for insertion of i-gel |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2019/08/03 09:13:47 |
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Basic information
Public title
Investigation for insertion of i-gel
Acronym
Investigation for insertion of i-gel
Scientific Title
Investigation for insertion of i-gel
Scientific Title:Acronym
Investigation for insertion of i-gel
Region
| Japan |
Condition
Condition
Cases, inserted the i-gel
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of insertion success
Key secondary outcomes
Number of insertion success
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
Cases, inserted the i -gel
Key exclusion criteria
Cases, not inserted the i-gel
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Ueshima |
Organization
Showa university hospital
Division name
Anesthesiology
Zip code
142-8666
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8575
ueshimhi@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Ueshima |
Organization
Showa university hospital
Division name
Anesthesiology
Zip code
142-8666
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8575
Homepage URL
ueshimhi@med.showa-u.ac.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
Showa university hospital
Address
1-5-8, hatanodai, shinagawa-ku, tokyo
Tel
03-3784-8575
03-3784-8575
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
| 2018 | Year | 01 | Month | 31 | 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
500
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
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
general anesthesia between April and September, 2017
the cases, inserted the i-gel
the success rate of the i-gel insertion
the success number of the i-gel insertion
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2019 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035485
