Trials / Unknown
UnknownNCT03774199
NightOwl Pulse Oximeter Calibration Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Ectosense NV · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Accepted
Summary
Calibration of a software module that computes SpO2 based on photoplethysmography (PPG) traces acquired by a reflectance-based pulse oximeter which can be placed on the index finger or the forehead. The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601- 2-61:2011)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NightOwl | The NightOwl is a finger and/or forehead mounted device with, among other functions, the capability to acquire double-wavelength PPG, from which SpO2 can be derived |
Timeline
- Start date
- 2018-12-14
- Primary completion
- 2019-12-14
- Completion
- 2020-04-14
- First posted
- 2018-12-12
- Last updated
- 2019-03-21
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03774199. Inclusion in this directory is not an endorsement.