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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04144699
Other study ID # HDV-CDD-190046
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 31, 2021

Study information

Verified date September 2021
Source Omron Healthcare Co., Ltd.
Contact Naoto Ohgami
Phone +81-75-925-2304
Email naoto.ogami@omron.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date December 31, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Months to 8 Years
Eligibility Inclusion Criteria: Mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis patients who meet all of the following criteria are considered as eligible. 1. Does the subject have mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis? 2. Is the subject between the ages of 3 months to 8 years old? 3. Is the parent or legal guardian available, and capable and willing to give a consent on the child's behalf. Exclusion Criteria: The subjects will be excluded from the study, if they have any of the following criteria. 1. Does the subject have skin rashes or wounds on the chest? 2. Does the subject have known allergies or irritant contact dermatitis or having hypersensitive skin? 3. Does the subject have a defibrillator and/or pacemaker (which could interfere with the sounds to be detected)? 4. Does the subject have an allergy to disinfecting alcohol? 5. Does the subject have wheezes caused by not asthma, such as reflux esophagitis, pneumonia, vocal cord dysfunction, Tracheomatosis? 6. Does the subject have a heavy runny nose? 7. Is it difficult to hear auscultation due to the subject fussing, crying or vocalizing at data collection? 8. Is the subject having difficulty breathing or having severe symptoms? 9. Was the subject enrolled more than once for the same resulted breath sounds? - Note: The subject maybe enrolled once per arm (once wheezing, once non-wheezing).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Tekton Research Beaumont Texas
United States PMG Research of Bristol Bristol Tennessee
United States Tekton Research Chamblee Georgia
United States PMG Research of Charleston Charleston South Carolina
United States University of Chicago Chicago Illinois
United States Children's Hospital Medical Center Cincinnati Ohio
United States Meridian Clinical Research, LLC Dakota Dunes South Dakota
United States PMG Research of Knoxville Jefferson City Tennessee
United States PMG Research of DuPage Joliet Illinois
United States University of Wisconsin Madison Wisconsin
United States Long Island Jewish Medical Center New York New York
United States PMG Research of Raleigh Raleigh North Carolina
United States Tekton Research San Antonio Texas
United States Tekton Research San Antonio Texas
United States PMG Research of Winston-Salem Winston-Salem North Carolina

Sponsors (4)

Lead Sponsor Collaborator
Omron Healthcare Co., Ltd. Children's Hospital Medical Center, Cincinnati, University of Chicago, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the sensitivity and specificity of the Omron WheezeScan device The WheezeScan device will be compared to the gold standard, auscultation, which will be performed by a physician or a qualified healthcare professional with a minimum of 3 years' experience. All breath sounds will be recorded for comparison in case of discrepancy. Novemver 1, 2019 ~ November 30, 2021
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