NCT05194436CompletedNot Applicable
A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric Subjects and Use for Remote Auscultation
Aevice Health Pte. Ltd.1 site in 1 country35 target enrollmentStarted: April 23, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Wheeze is detected by physician and AeviceMD
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Wheeze is detected by physician and AeviceMD
Time Frame: 60 Seconds
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
Secondary Outcomes
- Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician(150 Seconds)
Investigators
Study Sites (1)
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