Healthy Volunteers Clinical Trial
Official title:
An Open Label, Clinical Performance Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)
Verified date | March 2018 |
Source | Léman Micro Devices SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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: |
Country | Name | City | State |
---|---|---|---|
Switzerland | EPFL | Lausanne |
Lead Sponsor | Collaborator |
---|---|
Léman Micro Devices SA |
Switzerland,
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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