Clinical Validation of Omron WheezeScan

September 10, 2021 updated by: Omron Healthcare Co., Ltd.
The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Chamblee, Georgia, United States, 30341
        • Completed
        • Tekton Research
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
          • Brenda Louise Giles, MD
      • Joliet, Illinois, United States, 60435
        • Completed
        • PMG Research of DuPage
    • New York
      • New York, New York, United States, 11042
        • Recruiting
        • Long Island Jewish Medical Center
        • Contact:
          • Maria Santiago, MD
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Completed
        • PMG Research of Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • PMG Research of Winston-Salem
        • Contact:
          • William Stewart, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Children's Hospital Medical Center
        • Contact:
          • Rachelle Ramsey, MD
        • Contact:
          • Sophie Kollin
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Completed
        • PMG Research of Charleston
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Completed
        • Meridian Clinical Research, LLC
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Completed
        • Pmg Research of Bristol
      • Jefferson City, Tennessee, United States, 37760
        • Completed
        • PMG Research of Knoxville
    • Texas
      • Beaumont, Texas, United States, 77706
        • Recruiting
        • Tekton Research
        • Contact:
          • Robert Bell, MD
      • San Antonio, Texas, United States, 78240
        • Completed
        • Tekton Research
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • Tekton Research
        • Contact:
          • Kenneth Etokhana, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin
        • Contact:
          • Manish N Shah, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 months to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate the sensitivity and specificity of the Omron WheezeScan device
Time Frame: Novemver 1, 2019 ~ November 30, 2021
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Omron Healthcare Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Chicago
University of Wisconsin, Madison
Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HDV-CDD-190046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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