Trials / Terminated
TerminatedNCT06112080
Wearable Auscultation Device Validation in Children
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 36 (actual)
- Sponsor
- Strados Labs, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 17 Years
- Healthy volunteers
- —
Summary
This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RESP™ Biosensor | The RESP™ Biosensor will be placed on all participants for immediate capture and comparison of lung sounds. |
Timeline
- Start date
- 2023-08-07
- Primary completion
- 2024-06-24
- Completion
- 2024-06-24
- First posted
- 2023-11-01
- Last updated
- 2024-07-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06112080. Inclusion in this directory is not an endorsement.