Trials / Completed
CompletedNCT03725462
Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- BioSerenity · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The aim is to evaluate the performance of Cardioskin and Neuronaute, two connected medical devices CE-marked, manufactured by Bioserenity. It's an open monocentric comparative clinical study, where subjects will test the Cardioskin device and/or the Neuronaute device.
Detailed description
With this study evulating the performance of two wireless, connected device of electrophysiological signal monitoring. The Cardioskin monitors electrocardiogram signal. The Neuronaute monitors electroencephalogram, electromyogram and electrocardiogram. This study will permit to optimize the devices performance. To the study, subjects of at least 18 years old will test Cardioskin and or Neuronaute device, without randomization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cardioskin | Subjects have a monitoring with cardioskin and comparator |
| DEVICE | Neuronaute | Subjects have a monitoring with Neuronaute and comparator |
Timeline
- Start date
- 2017-10-16
- Primary completion
- 2019-03-02
- Completion
- 2019-04-16
- First posted
- 2018-10-31
- Last updated
- 2019-07-09
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03725462. Inclusion in this directory is not an endorsement.