UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040941 |
|---|---|
| Receipt number | R000046745 |
| Scientific Title | Comparison of Impedance measurement value and biomarker measurement value |
| Date of disclosure of the study information | 2021/08/23 |
| Last modified on | 2020/09/07 08:36:30 |
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Basic information
Public title
Comparison of Impedance measurement value and biomarker measurement value
Acronym
Comparison of Impedance measurement value and biomarker measurement value
Scientific Title
Comparison of Impedance measurement value and biomarker measurement value
Scientific Title:Acronym
Comparison of Impedance measurement value and biomarker measurement value
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the measured value of Impedance measuring device and the measured value of biomarker for subjects of a wide range of ages and genders
Basic objectives2
Others
Basic objectives -Others
Human data collection for a wide range of ages and genders
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
None
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females from 20 to 69 years of age
Key exclusion criteria
(1) Subjects suffering from serious illness
(2) Subjects who cause skin damage due to contact with electrodes or excessive sweating
(3) Subjects using a cardiac pacemaker, connecting to electronic life support devices, or using implantable electronic devices
(4) Subjects who cannot sit or stop for 3 minutes (such as Parkinson's disease)
(5) Subjects using metallic cores of fingers or joints or prosthetic devices
(6) Subjects with missing limbs
(7) Subjects who took a large amount of alcohol or a stimulant (amphetamine) within 12 hours before the test
(8) Subjects with sinusitis or frontal sinusitis
(9) Subjects using an intrauterine device
(10) Subject who was judged to be inappropriate as a subject from the answers to the background questionnaire
(11) Subjects participating in other clinical studies at the start of this study
(12) Subjects who will be pregnant or breastfeeding during the study period
(13) Subjects who are judged to be unsuitable by the investigator
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Saito |
Organization
Medical Station Clinic
Division name
None
Zip code
154-0004
Address
3-12-8 Takaban, Meguro-ku, Tokyo
TEL
03-6452-2712
info@med-station.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Tsuji |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
s.tsuji@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
non-discloser
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
t.saito@ttc-smo.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
| 2021 | Year | 08 | Month | 23 | 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
| 2020 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of Impedance measurement value and biomarker measurement value
Management information
Registered date
| 2020 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046745
