Clinical Validation of Omron WheezeScan

NCT ID: NCT04144699

Last Updated: 2021-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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Conditions

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Asthma in Children Bronchitis Bronchiolitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Wheezing 3~11months

Patient has wheezing, age 3 to 11 months

No interventions assigned to this group

Wheezing 12~23months

Patient has wheezing, age 12 to 23 months

No interventions assigned to this group

Wheezing 24~35months

Patient has wheezing, age 24 to 35 months

No interventions assigned to this group

Wheezing 36~107months

Patient has wheezing, age 36 to 107 months

No interventions assigned to this group

No wheezing 3~11months

Patient do not have wheezing, age 3 to 11 months

No interventions assigned to this group

No wheezing 12~23months

Patient do not have wheezing, age 12 to 23 months

No interventions assigned to this group

No wheezing 24~35months

Patient do not have wheezing, age 24 to 35 months

No interventions assigned to this group

No wheezing 36~107months

Patient do not have wheezing, age 36 to 107 months

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

3 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role collaborator

Omron Healthcare Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tekton Research

Chamblee, Georgia, United States

Site Status COMPLETED

University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

PMG Research of DuPage

Joliet, Illinois, United States

Site Status COMPLETED

Long Island Jewish Medical Center

New York, New York, United States

Site Status RECRUITING

PMG Research of Raleigh

Raleigh, North Carolina, United States

Site Status COMPLETED

PMG Research of Winston-Salem

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

PMG Research of Charleston

Charleston, South Carolina, United States

Site Status COMPLETED

Meridian Clinical Research, LLC

Dakota Dunes, South Dakota, United States

Site Status COMPLETED

PMG Research of Bristol

Bristol, Tennessee, United States

Site Status COMPLETED

PMG Research of Knoxville

Jefferson City, Tennessee, United States

Site Status COMPLETED

Tekton Research

Beaumont, Texas, United States

Site Status RECRUITING

Tekton Research

San Antonio, Texas, United States

Site Status COMPLETED

Tekton Research

San Antonio, Texas, United States

Site Status RECRUITING

University of Wisconsin

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Naoto Ohgami

Role: CONTACT

+81-75-925-2304

Katie May

Role: CONTACT

Facility Contacts

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Brenda Louise Giles, MD

Role: primary

Maria Santiago, MD

Role: primary

William Stewart, MD

Role: primary

Rachelle Ramsey, MD

Role: primary

Sophie Kollin

Role: backup

Robert Bell, MD

Role: primary

Kenneth Etokhana, MD

Role: primary

Manish N Shah, MD, MPH

Role: primary

Other Identifiers

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HDV-CDD-190046

Identifier Type: -

Identifier Source: org_study_id

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