Status:
COMPLETED
PULSE OXIMETRY Performance Test for a Software Medical Device 'Vitacam'
Lead Sponsor:
Vitacam
Collaborating Sponsors:
Tampere University
Tampere University Hospital
Conditions:
Pulse Oximetry
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
This clinical investigation aims to collect data for algorithm development and testing of Vitacam as well as to later validate the system using a simultaneously collected, but segregated, hold-out val...
Eligibility Criteria
Inclusion
- Age: 18-40 years
- ASA category 1
- Positive Allen's test
- Passing the physical examination
- Ability to give informed consent
- Volunteering for the study
- Fluent Finnish or English
Exclusion
- Age under 18 years or over 40 years
- Smoker
- Pregnancy
- Does not pass the physical examination
- Negative Allen's test
- Relevant medical illnesses
- Cardiovascular disease
- Pulmonary disease
- Inability to give informed consent
- Denial
Key Trial Info
Start Date :
December 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06912516
Start Date
December 22 2023
End Date
November 1 2024
Last Update
April 4 2025
Active Locations (1)
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1
Tampere University
Tampere, Finland, Finland, FI-33014