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

March 5, 2018 updated by: Léman Micro Devices SA

An Open Label, Clinical Performance Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome is satisfactory evidence of substantial equivalence of each of the five vital signs with the reference devices within the ranges specified by the standards.
Time Frame: DAY 1
Accuracy of investigational device compared to the reference devices.
DAY 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Léman Micro Devices SA

Investigators

  • Study Director: Chris Elliott, Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • LMD_CT_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe