UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016895 |
|---|---|
| Receipt number | R000019609 |
| Scientific Title | Observation of the fungiform taste buds using confocal laser scanning laser microsopy |
| Date of disclosure of the study information | 2015/03/24 |
| Last modified on | 2015/03/24 15:06:34 |
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Basic information
Public title
Observation of the fungiform taste buds using confocal laser scanning laser microsopy
Acronym
Observation of human fungiform taste buds
Scientific Title
Observation of the fungiform taste buds using confocal laser scanning laser microsopy
Scientific Title:Acronym
Observation of human fungiform taste buds
Region
| Japan |
Condition
Condition
Patients with severed chorda tympani nerve during middle ear surgery
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the time course until the fungifrom taste buds disappear and regenerate after severing the human chorda tympani nerve
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
How many days are needed until the fungiform taste buds disappear, and how many months are needed until the taste buds regenerate after severing the human chorda tympani nerve.
Key secondary outcomes
Same fungiform papillae are periodically observed using confocal laser scanning microscopy.
Base
Study type
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Consecutive 7 cases with sebered chorda tympani nerve during middle ear surgery
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with severed chorda tympani nerve during middle ear surgery
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehisa Saito |
Organization
University of Fukui
Division name
Faculty of medicine
Zip code
Address
Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-8407
takehisa@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehisa Saito |
Organization
University of Fukui
Division name
Faculty of medicine
Zip code
Address
Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-8407
Homepage URL
takehisa@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Science and Culture
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
福井大学医学部付属病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 24 | Day |
Last modified on
| 2015 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019609
