UMIN-CTR Clinical Trial

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
Email	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
Email	s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046745