A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric and Adult Populations

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Respiratory signs and symptoms consisting of wheeze, cough, and breathlessness are obtained in a manual fashion through history taking and physical examination by the healthcare professional. Auscultation of the lung assesses airflow through the trachea-bronchial tree and is helpful in diagnosing various respiratory disorders. AeviceMD is a wearable device that can acquire and process lung sounds, thus assisting in the detection of abnormal lung sounds. The primary objective of this study is to determine if AeviceMD can detect wheeze of pediatrics and adults as accurately as a physician through auscultation. The secondary objective is to investigate if AeviceMD can be used for remote auscultation of breath sounds.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Healthy Volunteers: f
View:

• The subject is willing and/or parents/guardians are able to give informed consent for participation in the study.

• Male or Female, aged ≥ 3 years.

• Diagnosed with acute asthma exacerbation by an ED provider.

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Sunit P. Jariwala, Professor, M.D.
sjariwal@montefiore.org
718-920-6089
Backup
Carlos L. Lutz, Assistant Professor, M.D.
clutz@montefiore.org
718-920-6626
Time Frame
Start Date: 2023-06-29
Estimated Completion Date: 2026-12
Participants
Target number of participants: 160
Treatments
Patients diagnosed with acute asthma exacerbation
Patients diagnosed with acute asthma exacerbation
Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis
Patient with a non-cardiac AND non-pulmonary chief complaint and discharge diagnosis
Related Therapeutic Areas
Sponsors
Leads: Aevice Health Pte. Ltd.
Collaborators: Montefiore Medical Center

This content was sourced from clinicaltrials.gov