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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031872
Receipt No. R000036174
Scientific Title Non-invasive measurement of pulmonary compliance using a photoelectric pulse wave sensor in chronic respiratory diseases
Date of disclosure of the study information 2018/04/01
Last modified on 2018/03/23

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Basic information
Public title Non-invasive measurement of pulmonary compliance using a photoelectric pulse wave sensor in chronic respiratory diseases
Acronym Non-invasive measurement of pulmonary compliance using a photoelectric pulse wave sensor in chronic respiratory diseases
Scientific Title Non-invasive measurement of pulmonary compliance using a photoelectric pulse wave sensor in chronic respiratory diseases
Scientific Title:Acronym Non-invasive measurement of pulmonary compliance using a photoelectric pulse wave sensor in chronic respiratory diseases
Region
Japan

Condition
Condition pulmonary diseases
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of usefulness of non-invasive pulmonary compliance measurement system using photoelectric pulse wave sensor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pulmonary compliance
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Dynamic compliance will be mearured using electorophotomeric sensor at basline (before treatment), 3 months, 6 months, 9 months and 12 months after treatment
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with chronic respiratory diseases who regurarily visit at outpatient clinic of Juntendo University Hospital and have given written informed consent after the explanation of study.
Key exclusion criteria Patients who have comorbidities that would influence pathophysiological condition of thelungs.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kuniaki Seyama
Organization Juntendo University Faculty of Medicine and Graduate School of Medicine
Division name Respiratory Medicine
Zip code
Address 3-1-3 Hongo Bunkyo-ku Tokyo
TEL 03-5802-1063
Email kseyama@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kuniaki Seyama
Organization Juntendo University Faculty of Medicine and Graduate School of Medicine
Division name Respiratory Medicine
Zip code
Address 3-1-3 Hongo Bunkyo-ku Tokyo
TEL 03-5802-1063
Homepage URL
Email kseyama@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization DENSO Corporation
New Business Promotion DIV.
Healthcare Business Dept.
Organization
Division
Category of Funding Organization Other
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 01 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 23 Day
Last modified on
2018 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036174

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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