Brief Summary
The primary objective of this study is to determine if Aevice Medical Device can detect wheeze as accurately as a physician through auscultation. The secondary objective is to investigate if Aevice Medical Device can be used for remote auscultation of the lung.
Brief Title
Wheeze Detection Using Aevice Medical Device
Completion Date
Completion Date Type
Actual
Conditions
Subject Presenting Wheeze
COPD
Asthma
Eligibility Criteria
Inclusion Criteria:
* The subject is willing and parents/guardians are able to give informed consent for participation in the study.
* Male or Female, aged 3 -18 years.
* Presenting with wheeze.
* Able (in the Investigators opinion) and willing to comply with all study requirements
Exclusion Criteria:
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subjects at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.
* The subject is willing and parents/guardians are able to give informed consent for participation in the study.
* Male or Female, aged 3 -18 years.
* Presenting with wheeze.
* Able (in the Investigators opinion) and willing to comply with all study requirements
Exclusion Criteria:
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subjects at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.
Inclusion Criteria
Inclusion Criteria:
* The subject is willing and parents/guardians are able to give informed consent for participation in the study.
* Male or Female, aged 3 -18 years.
* Presenting with wheeze.
* Able (in the Investigators opinion) and willing to comply with all study requirements
* The subject is willing and parents/guardians are able to give informed consent for participation in the study.
* Male or Female, aged 3 -18 years.
* Presenting with wheeze.
* Able (in the Investigators opinion) and willing to comply with all study requirements
Gender
All
Gender Based
false
Keywords
Wheeze
Auscultation
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
18 Years
Minimum Age
3 Years
NCT Id
NCT05194436
Org Class
Other
Org Full Name
Aevice Health Pte. Ltd.
Org Study Id
AE_MD_001
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric Subjects and Use for Remote Auscultation
Primary Outcomes
Outcome Description
Primary end point of wheeze will be captured in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the physician during manual auscultation. AeviceMD will perform wheeze analysis on each 5 sec of recording
Outcome Measure
Wheeze is detected by physician and AeviceMD
Outcome Time Frame
60 Seconds
Secondary Outcomes
Outcome Description
Secondary end point of normal, adventitious and lack of breath sounds will be captured in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the physician during manual auscultation - i.e. bronchovesicular, crackles. Normal, adventitious and lack of breath sounds will be annotated in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the independent physician during remote auscultation - i.e. bronchovesicular, crackles
Outcome Time Frame
150 Seconds
Outcome Measure
Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Study will include 35 patients who are admitted for exacerbations of chronic airway disease (i.e. Asthma)
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
18
Minimum Age Number (converted to Years and rounded down)
3
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sunit Jariwala
Investigator Email
sjariwal@montefiore.org