Clinical Validation of Omron WheezeScan

Last updated: September 10, 2021
Sponsor: Omron Healthcare Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bronchitis

Bronchitis (Pediatric)

Respiratory Syncytial Virus (Rsv) Infection

Treatment

N/A

Clinical Study ID

NCT04144699
HDV-CDD-190046
  • Ages 3-8
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: Mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis patients whomeet all of the following criteria are considered as eligible.

  1. Does the subject have mild to moderate diagnosed or suspected asthma, bronchitis, orbronchiolitis?
  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 consenton the child's behalf.

Exclusion

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 havinghypersensitive skin?
  3. Does the subject have a defibrillator and/or pacemaker (which could interfere with thesounds 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 vocalizingat 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

Total Participants: 240
Study Start date:
November 01, 2019
Estimated Completion Date:
December 31, 2021

Connect with a study center

  • Tekton Research

    Chamblee, Georgia 30341
    United States

    Completed

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • PMG Research of DuPage

    Joliet, Illinois 60435
    United States

    Completed

  • Long Island Jewish Medical Center

    New York, New York 11042
    United States

    Active - Recruiting

  • PMG Research of Raleigh

    Raleigh, North Carolina 27609
    United States

    Completed

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • PMG Research of Charleston

    Charleston, South Carolina 29403
    United States

    Completed

  • Meridian Clinical Research, LLC

    Dakota Dunes, South Dakota 57049
    United States

    Completed

  • PMG Research of Bristol

    Bristol, Tennessee 37620
    United States

    Completed

  • PMG Research of Knoxville

    Jefferson City, Tennessee 37760
    United States

    Completed

  • Tekton Research

    Beaumont, Texas 77706
    United States

    Active - Recruiting

  • Tekton Research

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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