UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023255 |
|---|---|
| Receipt number | R000024477 |
| Scientific Title | Study of swallowing evaluation method by ultrasound using a viscous air bubble liquid |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2016/07/20 17:29:16 |
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Basic information
Public title
Study of swallowing evaluation method by ultrasound using a viscous air bubble liquid
Acronym
Study of swallowing evaluation method by ultrasound
Scientific Title
Study of swallowing evaluation method by ultrasound using a viscous air bubble liquid
Scientific Title:Acronym
Study of swallowing evaluation method by ultrasound
Region
| Japan |
Condition
Condition
Normal adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the purpose of development of the swallowing function evaluation using ultrasound, to investigate the effectiveness of the liquid containing bubbles in order to clear a representation of an ultrasound image.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirmation of the contrast effect on the ultrasound image
Key secondary outcomes
Calculation of visualization rate of swallowing
Evaluation of the tongue movement
Evaluation of the epiglottis movement
Evaluation of the soft palate movement
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
| Maneuver |
Interventions/Control_1
Oral ingestion of the micro bubble containing liquid
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 and Female
Key inclusion criteria
There is no hindrance in daily life, swallowing function is normal adult
Key exclusion criteria
Failure of oral function, those with a history or having a disease of the maxillofacial area
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Murata Naomichi |
Organization
Okayama University
Division name
Special Needs Dentistry
Zip code
Address
2-5-1 Shikata-cho Kita-ku Okayama city
TEL
086-235-6823
murata-n@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Murata Naomichi |
Organization
Okayama University Hospital
Division name
Center for the Special Needs Dentistry
Zip code
Address
2-5-1 Shikata-cho Kita-ku Okayama city
TEL
086-235-6823
Homepage URL
murata-n@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 20 | Day |
Last modified on
| 2016 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024477
