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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002355
Receipt No. R000002824
Scientific Title Vibration Response Imaging and Pulmonary Function: Comparing healthy subjects and patients of pulmonary diseases.
Date of disclosure of the study information 2009/09/01
Last modified on 2016/03/22

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Basic information
Public title Vibration Response Imaging and Pulmonary Function: Comparing healthy subjects and patients of pulmonary diseases.
Acronym Vibration Response Imaging and Pulmonary Function
Scientific Title Vibration Response Imaging and Pulmonary Function: Comparing healthy subjects and patients of pulmonary diseases.
Scientific Title:Acronym Vibration Response Imaging and Pulmonary Function
Region
Japan

Condition
Condition Healtyh subjects and patients of pulmonary diseases (pleural effusion, lung cancer, asthma, COPD, etc)
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To characterize VRI patterns of healthy Japanese.
To analyze the VRI images of patients of pulmonary diseases compared to healthy subjects.
To analyze the effects of treatment on VRI image in pulmonary diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Effects of sex, age, physiqe, and smoking on VRI findings.
VRI pattern characteristics of various pulmonary diseases.
Change of VRI findings before and after treatment.
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 VRI recording
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subject is able to read and understand the Informed Consent Form and he/she will sign the Informed Consent.

Definition of Healthy subjects:
Subject is healthy, confirmed with physical examination and is not under treatment for respiratory tract disease.
Subject has no histories of operations for pulmonary diseases.

Key exclusion criteria Chest wall deformity;
Spine deformity (including severe scoliosis or kyphosis);
Hirsutism;
Potentially contagious skin lesion on the back;
Skin lesion that would interfere with sensor placement;
Patient is pregnant;
Cardiac pacemaker or implantable defibrillator;
Target sample size 370

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masamichi Mineshita
Organization St.Marianna University School of Medicine
Division name Respiratory and Infectious Diseases
Zip code
Address 2-16-1Sugao, Miyamae-ku, Kawasaki-City, Kanagawa
TEL 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masamichi Mineshita
Organization St.Marianna University School of Medicine
Division name Respiratory and Infectious Diseases
Zip code
Address
TEL
Homepage URL
Email m-mine@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medicine
Respiratory and Infectious Diseases
Institute
Department

Funding Source
Organization Deep Breeze Co., Israel.
Organization
Division
Category of Funding Organization Outside Japan
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
2009 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2007 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 20 Day
Last modified on
2016 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002824

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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