Trials / Unknown
UnknownNCT03340441
Prizma Device Temperature Measurement
Clinical Evaluation for Body Temperature Measurement Using Prizma Smart Phone Cover and Application
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- G Medical Innovations Ltd. · Industry
- Sex
- All
- Age
- 17 Years – 70 Years
- Healthy volunteers
- —
Summary
The purpose of the study is to evaluate the temperature measurements by the Prizma device.
Detailed description
Primary objective of this study is to compare the temperature measured by the PRIZMA to the oral and Armpit temperature measured by a gold standard device in order to develop and evaluate a skin to body temperature conversion table. Secondary objective is to collect and compare data of ECG, Respiration and SpO2 collected from the Prizma device to the data collected from gold standard devices for reference of noise level and for future development of the PRIZMA device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Prizma | sensor unit with mobile application installed on smartphone |
Timeline
- Start date
- 2017-04-19
- Primary completion
- 2017-12-01
- Completion
- 2017-12-30
- First posted
- 2017-11-13
- Last updated
- 2017-11-13
Locations
1 site across 1 country: Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03340441. Inclusion in this directory is not an endorsement.