UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021835 |
|---|---|
| Receipt number | R000025063 |
| Scientific Title | Establishment of a new quantitative swallowing function evaluation method by videofluoroscopic examination |
| Date of disclosure of the study information | 2016/04/10 |
| Last modified on | 2019/08/09 13:56:39 |
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Basic information
Public title
Establishment of a new quantitative swallowing function evaluation method by videofluoroscopic examination
Acronym
Establishment of a new quantitative swallowing function evaluation method
Scientific Title
Establishment of a new quantitative swallowing function evaluation method by videofluoroscopic examination
Scientific Title:Acronym
Establishment of a new quantitative swallowing function evaluation method
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Establish a temporal and quantitative evaluation method after optimaizing the density of contrast media.
Basic objectives2
Others
Basic objectives -Others
To discover different aspects of swallowing function in healthy adults
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative evaluation of swallowing function
Key secondary outcomes
The extent and incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
We perform a Videofluoroscopic examination normally.Then, subjects(healthy adult) drink water and the water including contrast media. We obseve the state that the liquid passes the esophagus from the oral cavity from the side in a radioscopy device.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healty adults can obtain the Imformed consent and do not have any problem of swallowing before this study.
Key exclusion criteria
1)history of hypersensitivity to iodine.
2)severe thyroid function disorders.
3)asthma
4)pregnancy,breast-feeding andthe possibility of pregnant women
5)The one who the medical doctors judged the participation in this study to be inappropriate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Sugamoto |
Organization
osaka university
Division name
Orthopedic biomaterial scinence
Zip code
565-0871
Address
2-2, Yamadaoka, Suita-shi, Osaka-Fu
TEL
06-6210-8444
sugamoto@ort.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Arai |
Organization
Satou Memorial Hospital
Division name
Department of Rehabilitation Medicine
Zip code
709-4312
Address
45, Kurotsuchi, Syoo-cho, Katsuta-gun, Okayama
TEL
0868-38-6688
Homepage URL
u236956c@ecs.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka university
Address
2-2, Yamadaoka, Suita-shi, Osaka-Fu
Tel
06-6210-8444
rinri@osaka-med.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
さとう記念病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 10 | 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
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
Main results already published
Date of protocol fixation
| 2015 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 08 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025063
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
