Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Wisconsin, Madison | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| University of Chicago | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis patients who meet all of the following criteria are considered as eligible.
Exclusion Criteria:
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?
Not provided
Not provided
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naoto Ohgami | Contact | +81-75-925-2304 | naoto.ogami@omron.com | |
| Katie May | Contact | katie.may@omron.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tekton Research | Completed | Chamblee | Georgia | 30341 | United States | |
| University of Chicago |
No plan to share the data
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 4, 2022 | |
| Reset | Jul 6, 2023 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 4, 2022 | Jul 6, 2023 |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D001988 | Bronchiolitis |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Patient do not have wheezing, age 36 to 107 months |
| Recruiting |
| Chicago |
| Illinois |
| 60637 |
| United States |
|
| PMG Research of DuPage | Completed | Joliet | Illinois | 60435 | United States |
| Long Island Jewish Medical Center | Recruiting | New York | New York | 11042 | United States |
|
| PMG Research of Raleigh | Completed | Raleigh | North Carolina | 27609 | United States |
| PMG Research of Winston-Salem | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
|
| Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| PMG Research of Charleston | Completed | Charleston | South Carolina | 29403 | United States |
| Meridian Clinical Research, LLC | Completed | Dakota Dunes | South Dakota | 57049 | United States |
| PMG Research of Bristol | Completed | Bristol | Tennessee | 37620 | United States |
| PMG Research of Knoxville | Completed | Jefferson City | Tennessee | 37760 | United States |
| Tekton Research | Recruiting | Beaumont | Texas | 77706 | United States |
|
| Tekton Research | Completed | San Antonio | Texas | 78240 | United States |
| Tekton Research | Recruiting | San Antonio | Texas | 78258 | United States |
|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53792 | United States |
|
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |