UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037972 |
|---|---|
| Receipt number | R000042935 |
| Scientific Title | Examination of A-P fluoroscopic image for different aspect of healthy swallowing using a new fluoroscopic method. |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/12/18 12:00:41 |
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Basic information
Public title
Examination of A-P fluoroscopic image for different aspect of healthy swallowing using a new fluoroscopic method.
Acronym
Examination of A-P fluoroscopic image for different aspect of healthy swallowing using a new fluoroscopic method.
Scientific Title
Examination of A-P fluoroscopic image for different aspect of healthy swallowing using a new fluoroscopic method.
Scientific Title:Acronym
Examination of A-P fluoroscopic image for different aspect of healthy swallowing using a new fluoroscopic method.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Applying a new evaluation method of swalling, which takes lateral view, reported by Arai et al, to evaluate the swallowing function of a healthy person using a front-view fluoroscopic image, and investigate the left-right difference of the size of bolus from the oropharynx to the hypopharynx.
Basic objectives2
Others
Basic objectives -Others
To examinate whether there is age and gender differences in swallowing style
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine whether there is a left-right difference between the oropharynx and the hypopharynx during swallowing water.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Using contrast agent
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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No dysphagia
Key exclusion criteria
Those with iodine allergy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Arai |
Organization
Kawasaki medical school
Division name
Rehabilitation medicine
Zip code
701-0192
Address
577 Matsushima, Kurashiki-shi, Okayama
TEL
086-462-1111
dodobiyan@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Arai |
Organization
Kawasaki medical school
Division name
Rehabilitation medicine
Zip code
701-0192
Address
577 Matsushima, Kurashiki-shi, Okayama
TEL
086-462-1111
Homepage URL
dodobiyan@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki medical school
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Kawasaki medical school
Address
577 Matsushima, Kurashiki-shi, Okayama
Tel
086-462-1111
kmscall@med.kawasaki-m.ac.jp
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
| 2024 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Writing a paper
Management information
Registered date
| 2019 | Year | 09 | Month | 09 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042935
