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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028123
Receipt No. 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

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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
Email 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
Email kato@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University Faculty of Medicine, Department of Physiology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032160

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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