UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052811 |
|---|---|
| Receipt number | R000060272 |
| Scientific Title | Investigation of the feasibility of measuring electrical conductivity with paper-based microfluidic chips using blood samples |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2024/04/25 15:50:20 |
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Basic information
Public title
Development of electrode sensors for body fluid measurement: Investigation of the possibility of measuring electrical conductivity using blood samples
Acronym
Investigation of the feasibility of measuring electrical conductivity with paper-based microfluidic chips using blood samples
Scientific Title
Investigation of the feasibility of measuring electrical conductivity with paper-based microfluidic chips using blood samples
Scientific Title:Acronym
Investigation of the feasibility of measuring electrical conductivity with paper-based microfluidic chips using blood samples
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the possibility of measuring electrical conductivity in human blood samples using paper-based microfluidic chips, which are electrode sensors for measuring body fluids.
Basic objectives2
Others
Basic objectives -Others
To investigate the correlation between blood viscosity measured by paper-based microfluidic chips measurement and blood viscosity calculated based on blood data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurability in blood samples
Key secondary outcomes
1. Correlation between electrical conductivity (viscosity) of whole blood and plasma
2. Correlation between electrical conductivity (viscosity) of whole blood or plasma and whole blood viscosity
3. Correlation between electrical conductivity (viscosity) of whole blood or plasma and blood test values such as glycolipid levels
4. Correlation between electrical conductivity (viscosity) of whole blood or plasma and AGEs score
5. Correlation between electrical conductivity (viscosity) of whole blood or plasma and body measurements
6. Adverse events
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire
2. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study
Key exclusion criteria
1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease
2. Subjects who had a serious injury or surgical history within 12 weeks prior to this study
3. Pre- or post-menopausal women having obvious changes in physical condition
4. Subjects donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study
5. Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study
6. Subjects who have cognitive disorder or who have possibility of the disorder
7. Subjects who participated and took the study drug in other clinical trials within four weeks prior to this study
8. Subjects who are judges as unsuitable for this study by the principal investigator or subinvestigators
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Health-Care Research Department of the University Hospital's Kiyotake Satellite Branch, Organization for Promotion of Research and Industry-Academic Regional Collaboration, University of Miyazaki
Zip code
889-1692
Address
Kihara5200, Kiyotake, Miyazaki889-1692, Japan
TEL
0985-85-9577
yasuji_arimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Health-Care Research Department, University of Miyazaki
Zip code
889-1692
Address
Kihara5200, Kiyotake, Miyazaki889-1692, Japan
TEL
0985-85-9577
Homepage URL
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Yoshitama Surface Finishing Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Kyushu Institute of Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.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
宮崎大学 研究・産学地域連携推進機構 医学部附属病院清武サテライトブランチ ヘルスケア研究部門（宮崎県）
Health-Care Research Department of the University Hospital's Kiyotake Satellite Branch, Organization for Promotion of Research and Industry-Academic Regional Collaboration, University of Miyazaki（Miyazaki）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | 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
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
| 2023 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 07 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 07 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 10 | Day |
Other
Other related information
Study design-Cross-sectional study.
-Items to be measured: Basic information of the participants, Vital signs (Blood Pressure, Heart Rate), Blood test((Hematological tests, biochemical examination of blood), body measurements (height, weight, BMI, abdominal circumference), body composition (muscle mass, extremity skeletal muscle mass, skeletal muscle mass index, fat mass, body fat percentage), visceral fat area, AGEs.
Electrical conductivity and viscosity of whole blood and plasma using paper-based microfluidic chips.
Management information
Registered date
| 2023 | Year | 11 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060272
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