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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034946
Receipt No. R000039618
Scientific Title Study of oral function evaluation with 3D camera
Date of disclosure of the study information 2018/11/21
Last modified on 2018/11/20

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Basic information
Public title Study of oral function evaluation with 3D camera
Acronym oral function test with 3D camera
Scientific Title Study of oral function evaluation with 3D camera
Scientific Title:Acronym oral function test with 3D camera
Region
Japan

Condition
Condition Dysphagia
Developmental disorder of stomatognathic function
Classification by specialty
Gastroenterology Rehabilitation medicine Dental medicine
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical investigation about relativeness between outersurface kinetics and inner swallowing dynamics
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)outersurface body kinetics
2)inner swallowing dynamics
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 1times
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
4 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Dysphagia
Key exclusion criteria normal
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sato Hideo
Organization Kagoshima University
Division name Pediatric Dentistry
Zip code
Address 8-35-1, Sakuragaoka, Kagoshima-shi
TEL 0992756262
Email k9039869@kadai.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sato Hideo
Organization Kagoshima University
Division name Pediatric Dentistry
Zip code
Address 8-35-1, Sakuragaoka, Kagoshima-shi
TEL 0992756262
Homepage URL
Email k9039869@kadai.jp

Sponsor
Institute Kagoshima University
Institute
Department

Funding Source
Organization Kagoshima University
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 21 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 20 Day
Last modified on
2018 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039618

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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