Trials / Recruiting
RecruitingNCT06691971
AeviceMD for Detection of Wheeze in Pediatric and Adult Populations
A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric and Adult Populations
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 160 (estimated)
- Sponsor
- Aevice Health Pte. Ltd. · Academic / Other
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Subject Presenting Wheeze
- Asthma
- Bronchial Disease
- Respiratory Tract Diseases
- Pediatric Asthma
- Chronic Respiratory Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AeviceMD | The AeviceMD device will be placed on the patient to detect the presence of wheeze and perform auscultation. |
Timeline
- Start date
- 2023-06-29
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2024-11-18
- Last updated
- 2025-10-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06691971. Inclusion in this directory is not an endorsement.