Trials / Active Not Recruiting
Active Not RecruitingNCT05876533
R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances
An Observational, Retrospective, Single-arm, Open US and Israel Study , for Usability Assessment and Algorithm, Development of the Cordio HearO™ Systeam
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 216 (actual)
- Sponsor
- Cordio Medical · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
To determine the usability and technical aspects of Cordio HearO™
Detailed description
The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options. The recordings data will also be used for algorithm improvement
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cordio HearO | Cordio HearO is a software medical device that remotely monitors Congestive Heart Failure (CHF) patients by detecting changes in the patients' recorded voice relative to a baseline. The system is comprised of a mobile application (or "app") that is deployed on a mobile platform, and a web-based portal that enables caregivers to manage their patients |
Timeline
- Start date
- 2022-03-18
- Primary completion
- 2025-01-31
- Completion
- 2025-03-15
- First posted
- 2023-05-25
- Last updated
- 2024-12-31
Locations
8 sites across 2 countries: United States, Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05876533. Inclusion in this directory is not an endorsement.