- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00495430
Vibration Response Imaging in Healthy Subjects
Passive Acoustic Imaging With the Vibration Response Imaging Device in Healthy Subjects
Study Overview
Status
Conditions
Detailed Description
Computerized analyses have shown that normal lung sounds have distinctive characteristic that can be differentiated from abnormal lung sounds.However, technical issues and complicated display modes have restricted the use of computerized lung sound analyses in the clinical environment.
The VRI provides dynamic gray-scale images and quantitative lung data showing the breath sound distribution of healthy individuals. Typical features that are discerned by trained raters and quantitative lung data may serve as a reference for comparison to abnormal breath sound images.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Haifa, Israel, 310196
- Rambam Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Able and willing to read, understands, and provides written Informed Consent;
- Male or Female in the age range of 18-85 years;
- Subject is healthy and has not exhibited symptoms of acute respiratory tract disease for the past two months;
- Subject has normal chest X-ray and normal lung function during the past 6 months that were judged stable;
- BMI > 21.
Exclusion Criteria:
- Subject has a history of a chronic condition that affects the lungs or heart (e.g.chronic obstructive pulmonary disease, asthma, congestive heart failure) or is suspected of having such a condition;
- Subject has a chest cage deformation;
- Subject has spine deformation (including severe scoliosis);
- Subject is Hirsute;
- Subject has a skin lesion (potentially contagious) on the back;
- Subject has a cardiac pacemaker or implantable defibrillator;
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mordechai Yigla, MD, Rambam Health Care Campus
Publications and helpful links
General Publications
- Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.
- Ploysongsang Y, Iyer VK, Ramamoorthy PA. Reproducibility of the vesicular breath sounds in normal subjects. Respiration. 1991;58(3-4):158-62. doi: 10.1159/000195918.
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DB013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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