UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002598 |
|---|---|
| Receipt number | R000003172 |
| Scientific Title | A construction of noninvasive examination of swallow function, substitute for videofluorography |
| Date of disclosure of the study information | 2009/10/08 |
| Last modified on | 2009/10/08 01:33:18 |
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Basic information
Public title
A construction of noninvasive examination of swallow function, substitute for videofluorography
Acronym
The establishment of the simple swallowing sensor
Scientific Title
A construction of noninvasive examination of swallow function, substitute for videofluorography
Scientific Title:Acronym
The establishment of the simple swallowing sensor
Region
| Japan |
Condition
Condition
Dysphasia
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We establish the noninvasive laboratory method of the swallowing function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compaired with videofluorogray
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Simultaneous examination of a swallowing sensor and the examination for Videofluorography
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Normal swallowing function
Key exclusion criteria
Swallowing functional decline
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Toyosato |
Organization
Kagoshima University Medical and Dental hospital
Division name
Dental Anesthesiology
Zip code
Address
8-choume 35-1 Sakuragaoka Kagoshima City
TEL
099-275-6561
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Toyosato |
Organization
Kagoshima University Medical and Dental hospital
Division name
Dental Anesthesiology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kagoshima University Medical and Dental hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (kakenhi)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 10 | Month | 08 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 08 | Day |
Last modified on
| 2009 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003172
