UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030803 |
|---|---|
| Receipt number | R000035173 |
| Scientific Title | Study of usefulness of pocket sized ultrasonography for evaluation of swallowing function |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2019/07/17 09:09:18 |
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Basic information
Public title
Study of usefulness of pocket sized ultrasonography for evaluation of swallowing function
Acronym
Usefulness of pocket sized ultrasonography in swallowing evaluation
Scientific Title
Study of usefulness of pocket sized ultrasonography for evaluation of swallowing function
Scientific Title:Acronym
Usefulness of pocket sized ultrasonography in swallowing evaluation
Region
| Japan |
Condition
Condition
Healthy condition
Target population: individuals with Dysphagia
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of pocket sized ultrasonography in examination of swallowing function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pocket sized versus portable Ultrasnography in imaging of thickness, cross-sectional area and fat mass of masseter muscles, tongue and suprahyoid muscles.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
One day, about an hour
3times per an examination
(1) Pocket sized ultrasonography
SONIMAGEP3 (KONICAMINOLTA Japnan, Inc)
(Medical Device Certification Number: 225ABBZX00129000)
(2) Portable ultrasonography
SonoSite M-Turbo (FUJIFILM, Corp)
(Medical Device Certification Number: 219ADBZI00197000)
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
Healthy volunteer with occlusal support
Key exclusion criteria
Individuals with systemic disease, dysphagia, respiratory disease, otorhinolaryngologic dease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Minakuchi |
Organization
Tokyo Medical and Dental University
Division name
Division of Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
TEL
03-5803-5559
haruka-t@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Tanaka |
Organization
Nihon university school of Dentistry at Matsudo
Division name
Division of Special Needs Dentistry
Zip code
271-8587
Address
2-87-1, sakaecho-nishi, Matsudo, Chiba, 271-8587, Japan
TEL
047-360-9443
Homepage URL
tanaka.yoko@nihon-u.ac.jp
Sponsor or person
Institute
Tokyo medical and dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical and dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nihon University School of Dentistry at Matsudo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon Universtiy School of Dentistry at Matsudo
Address
2-870-1, sakaecho-nichi, matsudo, Chiba
Tel
047-360-9443
tanaka.yoko@nihon-u.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
東京医科歯科大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | 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
Suspended
Date of protocol fixation
| 2018 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2008 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 14 | Day |
Last modified on
| 2019 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035173
| 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 |
