NCT02199457

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
2.9 years until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

July 11, 2014

Last Update Submit

March 5, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (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.

    Accuracy of investigational device compared to the reference devices.

    DAY 1

Study Arms (1)

SVSS and reference devices

OTHER

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

Interventions

SVSS and reference devicesDEVICE

Blood pressure will be measured with standard mercury manometer

SVSS and reference devices

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EPFL

Lausanne, Switzerland

Location

Study Officials

  • Chris Elliott

    Sponsor GmbH

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 24, 2014

Study Start

July 1, 2017

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)