UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022800 |
|---|---|
| Receipt number | R000026077 |
| Scientific Title | Evaluation of safety and usefulness of the wearable device for skin bioinstrumentation |
| Date of disclosure of the study information | 2016/06/21 |
| Last modified on | 2017/08/11 15:48:15 |
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Basic information
Public title
Evaluation of safety and usefulness of the wearable device for skin bioinstrumentation
Acronym
Evaluation of safety and usefulness of the wearable device
Scientific Title
Evaluation of safety and usefulness of the wearable device for skin bioinstrumentation
Scientific Title:Acronym
Evaluation of safety and usefulness of the wearable device
Region
| Japan |
Condition
Condition
1) Healthy adult
2) The person given informed consent in writing
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, the wearable device provides an important role in the measurement of the vital function. We developed the nano-mesh device which had breathability newly for the purpose of there was little feeling of wearing and getting the device which a measurement objectified the sense of a difficult person conventionally and could display. When gold nano mesh is stuck on skin, confirm whether you do not adversely affect skin. In addition, We perform an examination in comparison with the conventional matrix about influence on skin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of an allergic reaction and a primary irritant reaction, based on the criteria of the International Contact Dermatitis Research Group after seven days of an examination.
Key secondary outcomes
Evaluation of the influence to the three-dimensional shape of the skin (roughness, irregularity, etc.)
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
to confirm the adverse effect, when a newly developed wearable device are loaded on the skin
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 adult volunteers who declare the consent in writing for participating in this study.
Key exclusion criteria
The person with any severe skin symptoms in the study-site and with a serious cardiac and/or muscular disease. The person who have a metal allergy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ebihara |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
Address
35 Sinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3823
ebitamo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ebihara |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
Address
35 Sinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3823
Homepage URL
ebitamo@yahoo.co.jp
Sponsor or person
Institute
Department of Dermatology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Electrical and Electronic Engineering in School of engineering of the university of Tokyo, and Dermatology department in Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Electrical and Electronic Engineering,
School of Engineering, the University of Tokyo
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 | 06 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.nature.com/nnano/journal/vaop/ncurrent/full/nnano.2017.125.html?foxtrotcallback=true
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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2017 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026077
