UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028123 |
|---|---|
| Receipt number | R000032160 |
| Scientific Title | Safety test on light stimulation generated by a light stimulator meant for humans |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2018/07/19 15:52:02 |
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Basic information
Public title
Safety test on light stimulation generated by a light stimulator meant for humans
Acronym
Safety test on light stimulation
Scientific Title
Safety test on light stimulation generated by a light stimulator meant for humans
Scientific Title:Acronym
Safety test on light stimulation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to confirm the safety of a newly developed light stimulator.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
One week after the main test
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Light stimulation for approximately 2 hours
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who weigh between 30-90 kg.
Those who voluntarily submit a written informed consent.
Key exclusion criteria
1) Those who are in the course of drug treatment
2) Those who are pregnant
3) Those who currently suffers or have once suffered serious sensory or neuropsychiatric diseases
4) Those who have felt sick before while watching movies or playing electric games on a video apparatus.
5) Those whom the investigator judged to be excluded for whatever reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuo Kato |
Organization
Kanazawa Medical University Faculty of Medicine
Division name
Department of Physiology
Zip code
Address
Uchinada, Ishikawa
TEL
076-218-8102
kato@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuo Kato |
Organization
Kanazawa Medical University Faculty of Medicine
Division name
Department of Physiology
Zip code
Address
Uchinada, Ishikawa
TEL
076-218-8102
Homepage URL
kato@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University Faculty of Medicine, Department of Physiology
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University Faculty of Medicine, Department of Physiology
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
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
| 2017 | Year | 09 | 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
No harmful events occurred.
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
| 2017 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 09 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 09 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 09 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 07 | Day |
Last modified on
| 2018 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032160
| 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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