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Clinical Validation of Omron WheezeScan

O

Omron Healthcare

Status

Unknown

Conditions

Bronchiolitis
Asthma in Children
Bronchitis

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT04144699
HDV-CDD-190046

Details and patient eligibility

About

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

Enrollment

240 estimated patients

Sex

All

Ages

3 months to 8 years old

Volunteers

No Healthy Volunteers

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).

Trial design

240 participants in 8 patient groups

Wheezing 3~11months
Description:
Patient has wheezing, age 3 to 11 months
Wheezing 12~23months
Description:
Patient has wheezing, age 12 to 23 months
Wheezing 24~35months
Description:
Patient has wheezing, age 24 to 35 months
Wheezing 36~107months
Description:
Patient has wheezing, age 36 to 107 months
No wheezing 3~11months
Description:
Patient do not have wheezing, age 3 to 11 months
No wheezing 12~23months
Description:
Patient do not have wheezing, age 12 to 23 months
No wheezing 24~35months
Description:
Patient do not have wheezing, age 24 to 35 months
No wheezing 36~107months
Description:
Patient do not have wheezing, age 36 to 107 months

Trial contacts and locations

15

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Central trial contact

Naoto Ohgami; Katie May

Data sourced from clinicaltrials.gov

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