UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034835 |
|---|---|
| Receipt number | R000039724 |
| Scientific Title | Develop a new device using for nasal emission tests in cleft lip and palate |
| Date of disclosure of the study information | 2018/11/09 |
| Last modified on | 2019/06/13 15:15:24 |
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Basic information
Public title
Develop a new device using for nasal emission tests in cleft lip and palate
Acronym
Develop a new device using for nasal emission tests in cleft lip and palate
Scientific Title
Develop a new device using for nasal emission tests in cleft lip and palate
Scientific Title:Acronym
Develop a new device using for nasal emission tests in cleft lip and palate
Region
| Japan |
Condition
Condition
cleft lip and palate
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness of a new nasal examination device (camera) feeling of use, precision of nasal leakage, etc., compared with existing nasal cosmetics for patients cleaving the cleft lip and palate
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
difference between conventional method of nasal emission tests and a new device
Key secondary outcomes
impression from using
relations between each groups and success rate of tests
reliability of results from
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
For each cleft lip and cleft palate, a nasal examination and record is made at the 2nd, 4th, 6th, 8th month after each research registration
Interventions/Control_2
For each healthy infants,a nasal examination and record is made at the 2nd, 4th, 6th, 8th month after each research registration
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
| 2 | years-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cleft lip and palate patients
2-6 years old, unlimited by gender
post operation of palatoplasty
having no-remarkable basal disease for research
healthy children
2-6 years old and year matched with cleft lip and palate patients group
no cleft palate
having no-remarkable basal disease for research
Key exclusion criteria
Cleft lip and palate patients
not agree with research
difficult of periodical follow-up
inadequate for research
healthy children
not agree with research
inadequate for research
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rieko Doi |
Organization
Tottori University Hospital
Division name
oral and maxillofacial surgery
Zip code
Address
36-1 Nishi-cho Yonago Tottori Japan
TEL
0859-38-6687
rieko3@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rieko Doi |
Organization
Tottori University Hospital
Division name
oral and maxillofacial surgery
Zip code
Address
36-1 Nishi-cho Yonago Tottori Japan
TEL
0859-38-6687
Homepage URL
rieko3@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
nothjing
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
| 2018 | Year | 11 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Transition to other databases by clinical research method
Management information
Registered date
| 2018 | Year | 11 | Month | 09 | Day |
Last modified on
| 2019 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039724
