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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046745


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name