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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02199457
Other study ID # LMD_CT_001
Secondary ID
Status Withdrawn
Phase N/A
First received July 11, 2014
Last updated March 5, 2018
Start date July 2017
Est. completion date February 2018

Study information

Verified date March 2018
Source Léman Micro Devices SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2018
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SVSS and reference devices
Blood pressure will be measured with standard mercury manometer
SVSS and reference devices
Body temperature taken with infrared thermometer
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.
SVSS and reference devices
Measurement of respiration rate

Locations

Country Name City State
Switzerland EPFL Lausanne

Sponsors (1)

Lead Sponsor Collaborator
Léman Micro Devices SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Accuracy of investigational device compared to the reference devices. DAY 1
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