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 enrollmentApril 23, 2021

ConditionsSubject Presenting Wheeze COPD Asthma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Subject Presenting Wheeze
Sponsor: Aevice Health Pte. Ltd.
Enrollment: 35
Locations: 1
Primary Endpoint: Wheeze is detected by physician and AeviceMD
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 23, 2021

End Date

July 18, 2024

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Aevice Health Pte. Ltd.

Responsible Party

Sponsor

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.

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