Status:
UNKNOWN
V-Sensors for Vitals: Assessment of the Accuracy of a Vital Sign Sensor Mounted on a Smartphone
Lead Sponsor:
Léman Micro Devices SA
Conditions:
Clinical Accuracy of Vital Sign Pressure Sensor
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clin...
Detailed Description
The five vital signs are blood pressure, pulse, respiration, SpO2, and temperature. The user tests two devices mounted on two smartphones. * Temperature: Each user will use the V-sensor mounted on a ...
Eligibility Criteria
Inclusion
- Informed Consent
- 18 and 80 years old
- no history or risk for developing lymphedema
- no arteriovenous fistula in the right arm
- no right limb amputation up to and including the right index finger
- ability to obtain 3 readings from the device during the screening/training session.
Exclusion
- history of arrhythmia
- arteriovenous fistula in the right arm
- lymphedema or high risk for developing lymphedema in the right arm
- inability to follow the procedures of the study
- inability to hold the study device as instructed
- inability to obtain 3 readings from the study device during the screening session
- previous enrolment into the current study
- enrolment of the Investigator or Sponsor, his/her family members, employees and other dependent persons.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03321851
Start Date
April 1 2018
End Date
September 1 2018
Last Update
March 6 2018
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