UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040495 |
|---|---|
| Receipt number | R000046221 |
| Scientific Title | To investigate the change of the bolus flow in pharyngeal cavity by Mendelssohn procedure using ARAI method. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/06/14 16:03:34 |
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Basic information
Public title
To investigate the change of the bolus flow in pharyngeal cavity by Mendelssohn procedure using ARAI method.
Acronym
To investigate the change of the bolus flow in pharyngeal cavity by Mendelssohn procedure using ARAI method.
Scientific Title
To investigate the change of the bolus flow in pharyngeal cavity by Mendelssohn procedure using ARAI method.
Scientific Title:Acronym
To investigate the change of the bolus flow in pharyngeal cavity by Mendelssohn procedure using ARAI method.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the changes in the flow of ingested water in the pharyngeal cavity by the Mendelssohn procedure, and to know the usefulness and limitations of the Mendelssohn procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discover the usefulness and limitations of Mendelssohn procedures
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Contrast intake
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
Speech therapists familiar with the Mendelssohn technique
Key exclusion criteria
Persons with iodine allergies
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | NOBUYUKI |
| Middle name | |
| Last name | ARAI |
Organization
Kawasaki Medical School
Division name
Department of 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
Department of 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
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
Kawasaki Medical School Hospital
Address
577 Matsushima, Kurashiki-shi, Okayama
Tel
086-462-1111
dodobiyan@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
| 2021 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2026 | 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
| 2020 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046221
