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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02199457

Enrollment

Registered

2014-07-24

Start date

2017-07-31

Completion date

2018-02-28

Last updated

2018-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

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.

Interventions

DEVICESVSS and reference devices

Blood pressure will be measured with standard mercury manometer

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026