UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057946 |
|---|---|
| Receipt number | R000066248 |
| Scientific Title | Remote instruction for videoendoscopy and videofluoroscopy |
| Date of disclosure of the study information | 2025/05/23 |
| Last modified on | 2025/05/23 15:08:47 |
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Basic information
Public title
Remote instruction for examination of swallowing
Acronym
Remote swallowing examination
Scientific Title
Remote instruction for videoendoscopy and videofluoroscopy
Scientific Title:Acronym
RI-VEVF
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To know the possibility of remote instruction for videoendoscopy and videofluoroscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire Survey
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Instruction during 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 20 years or older who are suspected of having dysphagia and are to undergo videoendoscopy and videofluoroscopy, who gave written informed consent.
Key exclusion criteria
Patients who have difficulty in obtaining written informed consent.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2167
otaka119@mac.com
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562-46-2311
Homepage URL
hkagaya2@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2025 | Year | 05 | Month | 23 | 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
| 2025 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066248
