UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018765 |
|---|---|
| Receipt number | R000021641 |
| Scientific Title | the study of the innervation of the lesser palatine nerve to the levator veli palatini muscle |
| Date of disclosure of the study information | 2015/08/24 |
| Last modified on | 2019/03/12 15:13:44 |
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Basic information
Public title
the study of the innervation of the lesser palatine nerve to the levator veli palatini muscle
Acronym
the study of the innervation of the lesser palatine nerve to the levator veli palatini muscle
Scientific Title
the study of the innervation of the lesser palatine nerve to the levator veli palatini muscle
Scientific Title:Acronym
the study of the innervation of the lesser palatine nerve to the levator veli palatini muscle
Region
| Japan |
Condition
Condition
cleft palate
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the study of tne innervation of the lesser palatine nerve
Basic objectives2
Others
Basic objectives -Others
anatomical study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
electromyogram of the levator veli palatini muscle during stimulating the lesse palatine nerve
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
we stimulate the lesser palatine nerve during surgery one time by NIM system3.0.
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
| 8 | months-old | <= |
Age-upper limit
| 20 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with wide cleft palate which may be treated by push back method exposing the lesser palatine nerve
Key exclusion criteria
patients with narrow cleft palate which may be treated by Furlow method not exposing the lesser palatine nerve
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shigehiko |
| Middle name | |
| Last name | Suzuki |
Organization
Kyoto University Hospital
Division name
Plastic Surgery
Zip code
6068507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL
075-751-3613
prs@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Kishimoto |
Organization
Kyoto University Hospital
Division name
Plastic Surgery
Zip code
6068507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL
075-751-3613
Homepage URL
gushi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
unknown
Address
unknown
Tel
unknown
unknown
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 24 | 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
| 2015 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 22 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021641
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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