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

NCT ID: NCT02199457

Last Updated: 2018-03-07

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

SVSS and reference devices

Intervention Type DEVICE

Blood pressure will be measured with standard mercury manometer

SVSS and reference devices

Intervention Type DEVICE

Body temperature taken with infrared thermometer

SVSS and reference devices

Intervention Type DEVICE

Pulse rate and Sp02 measured with a reference pulse oximter. The pulse oximeter is just clipped to the end of the finger.

SVSS and reference devices

Intervention Type DEVICE

Measurement of respiration rate

Interventions

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SVSS and reference devices

Blood pressure will be measured with standard mercury manometer

Intervention Type DEVICE

SVSS and reference devices

Body temperature taken with infrared thermometer

Intervention Type DEVICE

SVSS and reference devices

Pulse rate and Sp02 measured with a reference pulse oximter. The pulse oximeter is just clipped to the end of the finger.

Intervention Type DEVICE

SVSS and reference devices

Measurement of respiration rate

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Léman Micro Devices SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Elliott

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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EPFL

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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LMD_CT_001

Identifier Type: -

Identifier Source: org_study_id

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