Clinical trial NCT03321851: V-Sensors for Vitals: Assessment of the Accuracy of a Vital Sign Sensor Mounted on a Smartphone
Official title: An Open Label, Interventional, Clinical Performance and Validation Study to Demonstrate the Clinical Accuracy of of the V-Sensor in the Healthy Adult Population; Single Site in Switzerland
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical Accuracy of Vital Sign Pressure Sensor
Lead sponsor: Léman Micro Devices SA
Sponsor class: INDUSTRY
First posted: 2017-10-26
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant tests two equivalent vital sign sensors (devices under test) mounted on two different smartphones, one after another to assess accuracy of the device compared to equivalent reference devices.
Primary purpose: DIAGNOSTIC

Brief summary: This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clinical setting.

Detailed description: The five vital signs are blood pressure, pulse, respiration, SpO2, and temperature. The user tests two devices mounted on two smartphones.

* Temperature: Each user will use the V-sensor mounted on a smartphone to obtain his/her temperature interfaced with a temperature specific 'app'. Before and after the the temperature is obtained using the V-Sensor, the temperature will be obtained using an equivalent thermometer.
* Blood Pressure: Each user will test his/her blood pressure using the two sensors mounted on the two phones interfaced with a blood pressure specific 'app'. Before and after each measurement, a reference measurement using a mercury sphygmomanometer will be taken.
* Pulse, Respiration, SpO2: Each user will test his/her pulse, respiration, and SpO2 using 2 V-sensors mounted on two separate smartphones interfaced with a Pulse, Respiration, and SpO2 'app'. Before and after each measurement, a reference measurement using equivalent reference devices will be taken.

Eligibility criteria: Inclusion Criteria:

* Informed Consent
* 18 and 80 years old
* no history or risk for developing lymphedema
* no arteriovenous fistula in the right arm
* no right limb amputation up to and including the right index finger
* ability to obtain 3 readings from the device during the screening/training session.

Exclusion Criteria:

* history of arrhythmia
* arteriovenous fistula in the right arm
* lymphedema or high risk for developing lymphedema in the right arm
* inability to follow the procedures of the study
* inability to hold the study device as instructed
* inability to obtain 3 readings from the study device during the screening session
* previous enrolment into the current study
* enrolment of the Investigator or Sponsor, his/her family members, employees and other dependent persons.

Primary outcomes:
measure: Blood Pressure accuracy to the reference device within the ranges specified by the ISO standard 81060-2
timeFrame: 4 months
measure: Pulse Rate accuracy to the reference device within the ranges specified by the ISO 80601-2-61
timeFrame: 4 months
measure: Blood Oxygen accuracy to the reference device within the ranges specified by the ISO 80601-2-61.
timeFrame: 4 months
measure: Respiration rate accuracy
timeFrame: 4 months
measure: Temperature accuracy to the reference device with the ranges specified by the ISO 80601-2-56 & ATSM 1965 Standard.
timeFrame: 4 months
Secondary outcomes:
measure: No serious adverse device effects are reported.
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Leman Micro-Device
name: Chris J Elliott, PhD
role: STUDY_DIRECTOR
References: