A Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)
Not Applicable
Withdrawn
- Conditions
- Healthy Volunteers
- Interventions
- Device: SVSS and reference devices
- Registration Number
- NCT02199457
- Lead Sponsor
- Léman Micro Devices SA
- Brief Summary
A medical device study to assess the clinical accuracy and equivalence to reference devices of the SVSS to satisfy the requirements of the recognised applicable international standards.
- Detailed Description
The SVSS is designed to measure and display 5 vital signs: pulse rate, blood oxygen saturation (Sp02), blood pressure, body temperature and respiration rate. These results will be compared for accuracy with the results obtained using standard vital sign measurement equipment on the same subject.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Healthy volunteers, male or female, 18 yrs or older, willing and able to participate and sign the informed consent form.
Exclusion Criteria
- None.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SVSS and reference devices SVSS and reference devices Vital signs will be measured on the same subject with the reference devices and with the SVSS. The subject will have blood pressure, pulse, blood oxygen, body temperature and respiration rate measured using standard equipment. The same subject will then use the investigational device which measures all vital signs at the same time, by placing the index finger on a sensor.
- Primary Outcome Measures
Name Time Method Primary outcome is satisfactory evidence of substantial equivalence of each of the five vital signs with the reference devices within the ranges specified by the standards. DAY 1 Accuracy of investigational device compared to the reference devices.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
EPFL
🇨🇭Lausanne, Switzerland