UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032191
Receipt No. 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 2018/10/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Hayashi Takaharu
Organization Osaka police hospital
Division name Cardiovascular medicine
Zip code
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
Middle name
Last name Hayashi Takaharu
Organization Osaka police hospital
Division name Cardiovascular medicine
Zip code
Address 10-31 Kitayama-cho, Tennoji, Osaka
TEL +81-(0)6-6771-6051
Homepage URL
Email takaharu0866@yahoo.co.jp

Sponsor
Institute Osaka police hospital
Institute
Department

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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
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 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

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
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036604

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.