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

NCT02199457 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-03-07

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DEVICE

SVSS and reference devices

Blood pressure will be measured with standard mercury manometer

DEVICE

SVSS and reference devices

Body temperature taken with infrared thermometer

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.

DEVICE

SVSS and reference devices

Measurement of respiration rate

Sponsors & Collaborators

  • Léman Micro Devices SA

    lead INDUSTRY

Principal Investigators

  • Chris Elliott · Sponsor GmbH

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2017-12-31
Completion
2018-02-28

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02199457 on ClinicalTrials.gov