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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034835
Receipt No. R000039724
Official scientific title of the study 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 2018/11/09

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Basic information
Official scientific title of the study Develop a new device using for nasal emission tests in cleft lip and palate
Title of the study (Brief title) 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 Rieko Doi
Organization Tottori University Hospital
Division name oral and maxillofacial surgery
Address 36-1 Nishi-cho Yonago Tottori Japan
TEL 0859-38-6687
Email rieko3@med.tottori-u.ac.jp

Public contact
Name of contact person Rieko Doi
Organization Tottori University Hospital
Division name oral and maxillofacial surgery
Address 36-1 Nishi-cho Yonago Tottori Japan
TEL 0859-38-6687
Homepage URL
Email rieko3@med.tottori-u.ac.jp

Sponsor
Institute Tottori University Hospital
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 10 Month 01 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 09 Day
Last modified on
2018 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039724

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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