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

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ClinicalTrials.gov Identifier: NCT02199457
Recruitment Status : Withdrawn (Device development not completed)
First Posted : July 24, 2014
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Léman Micro Devices SA

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: SVSS and reference devices Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open Label, Clinical Performance Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers, male or female, 18 yrs or older, willing and able to participate and sign the informed consent form.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199457


Locations
Switzerland
EPFL
Lausanne, Switzerland
Sponsors and Collaborators
Léman Micro Devices SA
Investigators
Study Director: Chris Elliott Sponsor GmbH

Responsible Party: Léman Micro Devices SA
ClinicalTrials.gov Identifier: NCT02199457     History of Changes
Other Study ID Numbers: LMD_CT_001
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No