A Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)

Léman Micro Devices

Status: Withdrawn

Conditions: Healthy Volunteers

Treatments: Device: SVSS and reference devices

Study type: Interventional

Funder types: Industry

Identifiers

NCT02199457

LMD_CT_001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

SVSS and reference devices

Other group

Description:

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.

Treatment:

Device: SVSS and reference devices

Device: SVSS and reference devices

Device: SVSS and reference devices

Device: SVSS and reference devices