Wheeze Detection Using Aevice Medical Device

Asthma Clinical Trial

Official title:

A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric Subjects and Use for Remote Auscultation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194436
• Other study ID #: AE_MD_001
• Status: Recruiting
• Start date: April 23, 2021
• Est. completion date: November 2022

Study information

• Verified date: February 2022
• Source: AEvice Health Pte Ltd
• Contact: Dr Michael Teik Chung LIM
• Phone: 6779 5555
• Email: michael_tc_lim[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

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

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
AEvice Health Pte Ltd	National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wheeze is detected by physician and AeviceMD	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	60 Seconds
Secondary	Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician	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	150 Seconds