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Clinical Trials/NCT05194436
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

Sponsor
Aevice Health Pte. Ltd.
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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