UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055910 |
|---|---|
| Receipt number | R000063882 |
| Scientific Title | Evaluation of the thermophysiological functions in human volunteers exposed to millimeter-waves |
| Date of disclosure of the study information | 2024/10/22 |
| Last modified on | 2024/11/08 09:44:03 |
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Basic information
Public title
Evaluation of the thermophysiological functions in human volunteers exposed to millimeter-waves
Acronym
Evaluation of the thermophysiological functions in human volunteers exposed to millimeter-waves
Scientific Title
Evaluation of the thermophysiological functions in human volunteers exposed to millimeter-waves
Scientific Title:Acronym
Evaluation of the thermophysiological functions in human volunteers exposed to millimeter-waves
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate whether exposure of the human arm skin to a 60 GHz-millimeter wave change physiological parameters such as skin temperature and skin blood flow, and also to evaluate whether the thresholds of exposure intensities for the biological effects will be modified by subject's age or sex.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin temperature
Key secondary outcomes
Skin blood flow
Fingertip pulse wave
Thermal sensation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A sequential exposure of the human arm skin to a 60 GHz-millimeter wave
Interventions/Control_2
A sham exposure of the human arm skin to a 60 GHz-millimeter wave
Interventions/Control_3
A single exposure of the human arm skin to a 60 GHz-millimeter wave at low intensity
Interventions/Control_4
A single exposure of the human arm skin to a 60 GHz-millimeter wave at middle intensity
Interventions/Control_5
A single exposure of the human arm skin to a 60 GHz-millimeter wave at maximum intensity
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who
-have obtained their informed consent.
-are in good health
-are determined that they are eligible to participate in this study, based on the interview about their life history and lifestyle including the interview process.
Key exclusion criteria
Those who
-are determined to have a health condition at the time of consent.
-are found to have lied in their consent forms or declarations.
-are judged to have difficulty in participating in this study as a result of interviews regarding their life history, lifestyle, etc.
-are judged to have difficulty in conducting this study.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Masuda |
Organization
Kurume University School of Medicine
Division name
Dept. Environmental Health
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942-31-7552
bdxmsd@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Masuda |
Organization
Kurume University School of Medicine
Division name
Dept. Environmental Health
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942-31-7552
Homepage URL
bdxmsd@yahoo.co.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Internal Affairs and Communications
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido University, Aichi-Gakuin University, The University of Electro-Communications, Kitami Institute of Technology, Saga University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University School of Medicine
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
Tel
0942-65-3749
i-rinri@kurume-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
| 2024 | Year | 10 | Month | 22 | 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
| 2023 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 10 | 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
| 2024 | Year | 10 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063882
