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Sponsored by: |
KarmelSonix Ltd. |
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Information provided by: | KarmelSonix Ltd. |
ClinicalTrials.gov Identifier: | NCT00644462 |
The PulmoTrack® 2010 with WIM-PC™ Technologies device, indicated for acoustic pulmonary function measurement that quantifies the presence of wheezing. This study was designed in order to evaluate the efficacy and safety of using the WIM-PC™ device for wheeze detection during dynamic bronchial situations in asthmatic adult.
Condition | Intervention |
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Asthma, Bronchial |
Device: PulmoTrack® 2010 with WIM-PC™ Technologies |
Study Type: | Observational |
Study Design: | Case Control, Retrospective |
Official Title: | Wheeze Detection in Adults During Dynamic Bronchial Situations Measured by PulmoTrack® 2010 With WIM-PC™ Technologies Recording |
Estimated Enrollment: | 50 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Asthmatic subjects
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Device: PulmoTrack® 2010 with WIM-PC™ Technologies
wheeze detection during dynamic bronchial situations in infants
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2
Healthy subjects
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Device: PulmoTrack® 2010 with WIM-PC™ Technologies
wheeze detection during dynamic bronchial situations in infants
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Asthma is defined by the National Asthma Education and Prevention Program (NAEPP) guideline as a 'Chronic inflammatory disorder of the airways in which many cells and cellular elements play a role. The asthma guideline states that inflammation causes recurrent episodes of wheezing, breathlessness and chest tightness that are associated with widespread but variable airflow obstruction. Wheeze quantification by lung sounds analysis methods is objective, non invasive and has been shown to correlate with clinical status in asthma and bronchiolitis. The recording procedure is simple, requiring only the attachment of 4 ECG-size sensors to the chest wall. A 30-second recording is often adequate to obtain good quality data, where wheezes are detected and counted with high degree of accuracy.
Karmel Sonix Ltd has developed the PulmoTrack® 2010 with WIM-PC™ Technologies device, indicated for acoustic pulmonary function measurement that quantifies the presence of wheezing. This study was designed in order to evaluate the efficacy and safety of using the PulmoTrack® 2010 with WIM-PC™ Technologies device for wheeze detection during dynamic bronchial situations in asthmatic adults.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
asthmatic subjects or healthy subjects
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | KarmelSonix Ltd ( Dr. Hanna Levy ) |
Study ID Numbers: | KSI-WZA-01 |
Study First Received: | March 20, 2008 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00644462 History of Changes |
Health Authority: | Israel: Ethics Commission |
wheeze detection |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |