UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039620 |
|---|---|
| Receipt number | R000032279 |
| Scientific Title | A mouthguard-type physical sensor for measured physical information of a body and communication with and control of external devices |
| Date of disclosure of the study information | 2020/02/27 |
| Last modified on | 2020/02/27 16:50:35 |
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Basic information
Public title
A mouthguard-type physical sensor for measured physical information of a body and communication with and control of external devices
Acronym
Evaluation of a mouthguard-type physical sensor
Scientific Title
A mouthguard-type physical sensor for measured physical information of a body and communication with and control of external devices
Scientific Title:Acronym
Evaluation of a mouthguard-type physical sensor
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of novel measurement techniques for physical information of a body, and communication technology that connects a physical sensor and external device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Usefulness of measurement techniques for physical information obtained from a mouth
- Possibility to communicate with and control an external device using the measured physical data.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
A mouthguard-type physical sensor is attached in a subject's mouth to measure his/her oral physical quantity.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A healthy person who is not concerned and consented to the experiment.
Key exclusion criteria
- Have a metal allergy
- Have a health problem
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kohji |
| Middle name | |
| Last name | Mitsubayashi |
Organization
Tokyo Medical and Dental University
Division name
Institute of Biomaterials and Bioengineering
Zip code
1010062
Address
2-3-10 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-5280-8091
m.bdi@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kohji |
| Middle name | |
| Last name | Mitsubayashi |
Organization
Tokyo Medical and Dental University
Division name
Institute of Biomaterials and Bioengineering
Zip code
1010062
Address
2-3-10 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-5280-8091
Homepage URL
m.bdi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
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
Tokyo Medical and Dental University
Address
Institute of Biomaterials and Bioengineering
Tel
03-5280-8003
zaikensoumu.adm@cmn.tmd.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
| 2020 | Year | 02 | Month | 27 | 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
| 2017 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | 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 | 02 | Month | 27 | Day |
Last modified on
| 2020 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032279
