UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002355 |
|---|---|
| Receipt number | 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 16:26:16 |
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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
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
m-mine@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Respiratory and Infectious Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002824
