V-Sensors for Vitals: Assessment of the Accuracy of a Vital Sign Sensor Mounted on a Smartphone

Léman Micro Devices

Status: Unknown

Conditions: Clinical Accuracy of Vital Sign Pressure Sensor

Treatments: Device: V-sensor device user

Study type: Interventional

Funder types: Industry

Identifiers

NCT03321851

LMD-CT-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

V-Sensor Device User

Other group

Description:

This diagnostic medical device is designed to detect the user's 5 vital signs. Each user tests two sensors, each sensor is mounted on a smartphone. Each vital sign is compared to an equivalent reference device obtained by the healthcare provider.

Treatment:

Device: V-sensor device user