UMIN-CTR Clinical Trial

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
Email	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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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