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Asthma, Bronchial | Wheeze Detection in Adults During Dynamic Bronchial Situations Measured by PulmoTrack® 2010 With WIM-PC™ Technologies Recording

Asthma, Bronchial research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Asthma, Bronchial

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:PulmoTrack® 2010 with WIM-PC™ Technologieswheeze detection during dynamic bronchial situations in infants

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Asthmatic subjects

2Healthy subjects

Study Status

Unknown status

Start Date: June 2009

Completed Date: December 2009

Phase:

Type: Observational

Design:

Primary Outcome: 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.

Secondary Outcome: 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

Study sponsors, principal investigator, and references

Principal Investigator: Noam Gavriely, Prof.

Lead Sponsor: KarmelSonix Ltd.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00644462

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