UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049761 |
|---|---|
| Receipt number | R000056679 |
| Scientific Title | The comparison of the bolus made by devices and human. |
| Date of disclosure of the study information | 2022/12/15 |
| Last modified on | 2024/01/05 09:44:42 |
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Basic information
Public title
The comparison of the bolus made by devices and human.
Acronym
The comparison of the bolus made by devices and human.
Scientific Title
The comparison of the bolus made by devices and human.
Scientific Title:Acronym
The comparison of the bolus made by devices and human.
Region
| Japan |
Condition
Condition
Healthy male and female the age from 18 to under 65.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify bolus similarity between made by devices and human.
Basic objectives2
Others
Basic objectives -Others
Validation of bolus formation by devices.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Similarity of elongation viscosity, adhesion, friction coefficient and saliva absorption.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy male and female the age from 18 to under 65 at the time of informed consent.
2. Subjects who have agreed to participate in this study in written after received a full explanation of the purpose and content of this study.
Key exclusion criteria
1. Subjects with food allergies to wheat, eggs, milk, soybeans, beef, chicken, pork, apples and gelatin.
2. Subjects who take medicines that may reduce saliva secretion often.
3. Subjects with subjective symptoms of dry mouth (xerostomia).
4. Subjects with missing teeth other than third molars (wisdom teeth).
5. Subjects who feel uncomfortable with mastication.
6. Subjects with or undergoing treatment for jaw and oral system abnormalities.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Miura |
Organization
Iwate University
Division name
Faculty of Agriculture
Zip code
020-8550
Address
3-18-8 Ueda, Morioka, Iwate prefecture, Japan
TEL
019-621-6255
mako@iwate-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Inoue |
Organization
Meiji Co., Ltd
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, Japan
TEL
042-632-5824
Homepage URL
motoki.inoue@meiji.com
Sponsor or person
Institute
Iwate University
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate University Human Subjects Research Ethics Review Committee
Address
3-18-8 Ueda, Morioka City, Iwate Prefecture 020-8550, Japan
Tel
019-621-6851
ksokatsu@iwate-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 15 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment will be conducted within Iwate University and 12 persons who correspond the selection criteria will be selected.
Management information
Registered date
| 2022 | Year | 12 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056679
| 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 |
