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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Clinical Accuracy of Vital Sign Pressure Sensor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Vital sign results obtained by the device under study are not displayed on phone screen.

Study Groups

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V-Sensor Device User

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.

Group Type OTHER

V-sensor device user

Intervention Type DEVICE

Participants use device to detect the 5 vital signs (Blood Pressure, Pulse, Respiration, SpO2, Temperature).

Interventions

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V-sensor device user

Participants use device to detect the 5 vital signs (Blood Pressure, Pulse, Respiration, SpO2, Temperature).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes