Wheeze Detection in Adults During Dynamic Bronchial Situations Measured by PulmoTrack® 2010 With WIM-PC™ Technologies Recording
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJanuary 13, 2009
January 1, 2009
6 months
March 20, 2008
January 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Study success will be declared if one of the following is met: A correlation of at least 0.25 (R2=0.25) will be found between WR and FEV1 measurements; A correlation of at least 0.7 will be found between clinical parameter and WZ measurements.
6 months
Secondary Outcomes (1)
Evaluation of the safety of using the PulmoTrack® 2010 with WIM-PC™ Technologies for wheeze detection. Safety will be established by lack of adverse events. Since this is a Non Significant Risk (NSR) device serious adverse events are not expected
1 hour
Study Arms (2)
1
Asthmatic subjects
2
Healthy subjects
Interventions
wheeze detection during dynamic bronchial situations in infants
Eligibility Criteria
asthmatic subjects or healthy subjects
You may qualify if:
- Asthmatic or healthy subjects;
- Age 18 and up;
- Not smoking for at the last two years;
- Subject or subject's parents/guardian is able to comprehend and give informed consent for participation in the study.
You may not qualify if:
- Chest burns;
- COPD;
- Pregnant or lactating;
- Mechanically ventilatory;
- Homodynamic instability;
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening;
- Acute infection requiring intravenous antibiotics at the time of screening;
- Uncontrolled bleeding and coagulation disorders;
- Uncontrolled diabetes mellitus: IDDM or NIDDM;
- HIV positive or any other immunosuppressive disorder;
- Subject objects to the study protocol;
- Concurrent participation in any other clinical study;
- Physician objection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KarmelSonix Ltd.lead
Study Sites (1)
Bnei-Zion Medical Center
Haifa, 31048, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Noam Gavriely, Prof.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 20, 2008
First Posted
March 26, 2008
Study Start
June 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
January 13, 2009
Record last verified: 2009-01