UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038162 |
|---|---|
| Receipt number | R000043486 |
| Scientific Title | Video ultrasonographic examination of swallowing |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2021/05/22 23:38:57 |
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Basic information
Public title
Video ultrasonographic examination of swallowing
Acronym
Video ultrasonographic examination of swallowing
Scientific Title
Video ultrasonographic examination of swallowing
Scientific Title:Acronym
Video ultrasonographic examination of swallowing
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish ultrasonographic examination of swallowing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity and specificity of dysphagia by ultrasound
Key secondary outcomes
Pharyngeal residual, Swallowing reflex, Pharyngeal clearance, Early pharyngeal inflow, Vocal cord paralysis, Tongue fasciculation, Thyroid tumor
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
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
Ultrasound and endoscopy (single and simultaneous examination)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with dysphagia visited department of otolaryngology, Jichi medical university hospital
Key exclusion criteria
Patients with active epistaxis
Patients who can not intake carbonated water
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Yamauchi |
Organization
Jichi medical university
Division name
Department of Otolaryngology
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
+81285587381
96093ty@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Yamauchi |
Organization
Jichi medical university
Division name
Departmento of Otolaryngology
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
+81285587381
Homepage URL
https://www.jichi.ac.jp/kenkyushien/bioethics/disclosure.html
96093ty@jichi.ac.jp
Sponsor or person
Institute
Jichi medical university
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Jichi medical university clinical research support center
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
Tel
+81285588933
rinri@jichi.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
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 01 | 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
| 2019 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 09 | Month | 30 | Day |
Last modified on
| 2021 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043486
