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Wheeze Detection Using Aevice Medical Device

Sponsor
AEvice Health Pte Ltd (Other)
Overall Status
Recruiting
CT.gov ID
NCT05194436
Collaborator
National University Hospital, Singapore (Other)
35
Enrollment
1
Location
18.3
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: AeviceMD

Study Design

Study Type:
Observational
Anticipated Enrollment :
35 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric Subjects and Use for Remote Auscultation
Actual Study Start Date :
Apr 23, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Wheeze is detected by physician and AeviceMD [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 Outcome Measures

  1. Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician [150 Seconds]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 18 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National University Hospital Singapore Singapore 119074

Sponsors and Collaborators

  • AEvice Health Pte Ltd
  • National University Hospital, Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AEvice Health Pte Ltd
ClinicalTrials.gov Identifier:
NCT05194436
Other Study ID Numbers:
  • AE_MD_001
First Posted:
Jan 18, 2022
Last Update Posted:
Feb 15, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AEvice Health Pte Ltd
Wheeze
Auscultation

Study Results

No Results Posted as of Feb 15, 2022