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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02199457
• Other study ID #: LMD_CT_001
• Status: Withdrawn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
• 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• Status: Withdrawn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:

Related Conditions & MeSH terms

• Healthy Volunteers

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