UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032191
Receipt number R000036604
Scientific Title Verification of validity of the simple and no-invasive measurement of lung fluid volume using pulmonary fluid volume measurement device
Date of disclosure of the study information 2018/04/11
Last modified on 2020/04/13 17:50:02

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Basic information

Public title

Verification of validity of the simple and no-invasive measurement of lung fluid volume using pulmonary fluid volume measurement device

Acronym

measurement of lung fluid volume

Scientific Title

Verification of validity of the simple and no-invasive measurement of lung fluid volume using pulmonary fluid volume measurement device

Scientific Title:Acronym

measurement of lung fluid volume

Region

Japan


Condition

Condition

people who receive medical check up

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In order to evaluate the accuracy of the lung fluid volume measuring device (ReDSTM wearable system; Sensible Medical Innovations Ltd. ), especially the applicability to the Japanese, this study will be conducted to evaluate the correlation with the lung fluid volume measured by ReDS and the lung fluid volume measured by CT image and spirometer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between lung fluid estimated by ReDS and chest CT and spirometer

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who do not have a history of diagnosis of heart failure and are not
currently diagnosed with heart failure.
Patients who undergo chest CT and spirometer tests for medical diagnostic purposes or for medical diagnostic purposes or in health checkup.

Key exclusion criteria

Apparent obstructive respiratory disease
Patients who has previous lung operation
Patients who has abnormal finding of thoracic cage
CKD >G4(eGFR<30%)

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Takaharu
Middle name
Last name Hayashi

Organization

Osaka police hospital

Division name

Cardiovascular medicine

Zip code

5430035

Address

10-31 Kitayama-cho, Tennoji, Osaka

TEL

+81-(0)6-6771-6051

Email

takaharu0866@yahoo.co.jp


Public contact

Name of contact person

1st name Takaharu
Middle name
Last name Hayashi

Organization

Osaka police hospital

Division name

Cardiovascular medicine

Zip code

543-0035

Address

10-31 Kitayama-cho, Tennoji, Osaka

TEL

+81-(0)6-6771-6051

Homepage URL


Email

takaharu0866@yahoo.co.jp


Sponsor or person

Institute

Osaka police hospital

Institute

Department

Personal name



Funding Source

Organization

Teijin Pharma Co., Ltd.

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

Osaka Police Hospital Ethics Committee

Address

Osaka city, Tennoji-ku, kitayama-cho

Tel

+81-(0)6-6771-6051

Email

shomu@oph.gr.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

2018 Year 04 Month 11 Day


Related information

URL releasing protocol

we could not get positive results

Publication of results

Unpublished


Result

URL related to results and publications

we could not obtain enough result to publication

Number of participants that the trial has enrolled

70

Results

In our study, we could not find correlation with the lung fluid volume measured by ReDS and the lung fluid volume measured by CT image and spirometer.

Results date posted

2020 Year 04 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

male: 30
female: 40

Participant flow

Conducted in cases where consent was obtained in cases where a health examination was taken

Adverse events

none

Outcome measures

To evaluate the relationship between CT and ReDS.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2018 Year 03 Month 02 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 14 Day

Last follow-up date

2018 Year 08 Month 31 Day

Date of closure to data entry

2018 Year 08 Month 31 Day

Date trial data considered complete

2018 Year 08 Month 31 Day

Date analysis concluded

2018 Year 10 Month 30 Day


Other

Other related information

To evaluate the correlation with the lung fluid volume measured by ReDS and the lung fluid volume measured by CT image and spirometer.


Management information

Registered date

2018 Year 04 Month 11 Day

Last modified on

2020 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036604


Research Plan
Registered date File name
2020/04/13 ReDS研究計画書申請用.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/04/13 ReDS data.xlsx