UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046442 |
|---|---|
| Receipt number | R000052926 |
| Scientific Title | Usability confirmation test of mobile electroencephalograph in clinical environment |
| Date of disclosure of the study information | 2022/01/10 |
| Last modified on | 2022/12/23 11:02:55 |
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Basic information
Public title
Performance test of mobile electroencephalograph in hospital environment
Acronym
Performance test of mobile electroencephalograph in hospital environment
Scientific Title
Usability confirmation test of mobile electroencephalograph in clinical environment
Scientific Title:Acronym
Usability confirmation test of mobile electroencephalograph in clinical environment
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of the usability of the dry sensor type simple electroencephalograph in a clinical environment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the test device and the electroencephalograph obtained with the target device.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults without physical or mental illness.
Key exclusion criteria
Those who have undergone head surgery, who are participating in other clinical studies or clinical trials, who are pregnant.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Tomita |
Organization
Tohoku University, Graduate school of Medicine
Division name
Department of Psychiatry
Zip code
9808574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
TEL
0227177000
htomita@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sakuma |
Organization
Tohoku University Hospital
Division name
Department of Psychiatry
Zip code
9808574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
TEL
0227177000
Homepage URL
atsushi.sakuma.a1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Dainippon Pharma
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
Tel
0227284105
0227284105
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
| 2022 | Year | 01 | Month | 10 | 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
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052926
| 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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| Registered date | File name |
