Clinical Validation of Omron WheezeScan
1 other identifier
observational
240
1 country
15
Brief Summary
The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Typical duration for all trials
15 active sites
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
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 17, 2021
September 1, 2021
2.1 years
October 28, 2019
September 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (8)
Wheezing 3~11months
Patient has wheezing, age 3 to 11 months
Wheezing 12~23months
Patient has wheezing, age 12 to 23 months
Wheezing 24~35months
Patient has wheezing, age 24 to 35 months
Wheezing 36~107months
Patient has wheezing, age 36 to 107 months
No wheezing 3~11months
Patient do not have wheezing, age 3 to 11 months
No wheezing 12~23months
Patient do not have wheezing, age 12 to 23 months
No wheezing 24~35months
Patient do not have wheezing, age 24 to 35 months
No wheezing 36~107months
Patient do not have wheezing, age 36 to 107 months
Eligibility Criteria
Wheezing Total : Min.120, Wheezing 3\~11months : Min.19, Wheezing 12\~23months : Min.19, Wheezing 24\~35months : Min.19, Wheezing 36\~107months : Min.38, No wheezing total : Min.120, No wheezing 3\~11months : Min.19, No wheezing 12\~23months : Min.19, No wheezing 24\~35months : Min.19, No wheezing 36\~107months : Min.38
You may qualify if:
- Mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis patients who meet all of the following criteria are considered as eligible.
- Does the subject have mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis?
- Is the subject between the ages of 3 months to 8 years old?
- Is the parent or legal guardian available, and capable and willing to give a consent on the child's behalf.
You may not qualify if:
- The subjects will be excluded from the study, if they have any of the following criteria.
- Does the subject have skin rashes or wounds on the chest?
- Does the subject have known allergies or irritant contact dermatitis or having hypersensitive skin?
- Does the subject have a defibrillator and/or pacemaker (which could interfere with the sounds to be detected)?
- Does the subject have an allergy to disinfecting alcohol?
- Does the subject have wheezes caused by not asthma, such as reflux esophagitis, pneumonia, vocal cord dysfunction, Tracheomatosis?
- Does the subject have a heavy runny nose?
- Is it difficult to hear auscultation due to the subject fussing, crying or vocalizing at data collection?
- Is the subject having difficulty breathing or having severe symptoms?
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Omron Healthcare Co., Ltd.lead
- University of Wisconsin, Madisoncollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
- University of Chicagocollaborator
Study Sites (15)
Tekton Research
Chamblee, Georgia, 30341, United States
University of Chicago
Chicago, Illinois, 60637, United States
PMG Research of DuPage
Joliet, Illinois, 60435, United States
Long Island Jewish Medical Center
New York, New York, 11042, United States
PMG Research of Raleigh
Raleigh, North Carolina, 27609, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
PMG Research of Charleston
Charleston, South Carolina, 29403, United States
Meridian Clinical Research, LLC
Dakota Dunes, South Dakota, 57049, United States
PMG Research of Bristol
Bristol, Tennessee, 37620, United States
PMG Research of Knoxville
Jefferson City, Tennessee, 37760, United States
Tekton Research
Beaumont, Texas, 77706, United States
Tekton Research
San Antonio, Texas, 78240, United States
Tekton Research
San Antonio, Texas, 78258, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2019
First Posted
October 30, 2019
Study Start
November 1, 2019
Primary Completion
November 30, 2021
Study Completion
December 31, 2021
Last Updated
September 17, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share
No plan to share the data