Wheeze Detection Using Aevice Medical Device

NCT ID: NCT05194436

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-23

Study Completion Date

2024-07-18

Brief Summary

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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.

Detailed Description

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Conditions

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Subject Presenting Wheeze COPD Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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AeviceMD

The AeviceMD will be placed on the patient to detect wheeze and perform auscultation.

Intervention Type DEVICE

Other Intervention Names

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AeviceMD Monitoring System

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role collaborator

Aevice Health Pte. Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National University Hospital

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

Other Identifiers

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AE_MD_001

Identifier Type: -

Identifier Source: org_study_id

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