N/A
N=13
Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03614416 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position — 3.91; 3.08; 3.36; 2.85 percentage of ARMS (accuracy)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EOXY device (Device); Gold standard oximeter (Device); SaO2 sampling (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioSerenity
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position |
3.91; 3.08; 3.36; 2.85; 3.48; 6.21 | — |
| PRIMARY Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position |
11.14; 12.99; 12.51; 9.91; 7.31; 10.76 | — |
| PRIMARY Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position |
6.02; 7.09; 6.63; 6.57; 5.06; 3.96 | — |
| PRIMARY HR Accuracy Root-Mean Square (ARMS) at Forehead Position |
12.2; 10.0; 11.7; 11.5; 14.3; 13.0 | — |
| PRIMARY Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position |
32.1; 30.8; 31.5; 31.5; 30.4; 36.5 | — |
| PRIMARY Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position |
21.1; 22.3; 24.6; 19.2; 19.1; 20.6 | — |
Summary
The purpose of the study is to test the performance and safety of the Bioserenity pulse oxymeter EOXY. For that, and in agreement with ISO60601-2-61 norm and FDA regulation, measures of heart rate, with a gold-standard, and SaO2 measures generated by blood samples will be compared with Sp02 and heart rate measures that are generated by our EOXY.
Thirteen healthy subjects will participate in the study in total. Three subjects will be enrolled during a primary phase .They will participate at a secondary phase as well as ten others subjects. The purpose of the primary phase is to test the body area where the measurement can be done. The purpose of the secondary phase is to measure SpO2 and HR in desaturation conditions.
Eligibility Criteria
Inclusion Criteria
- Healthy subject (Man/ Women) > 18 years old
- Subject signed informed consent prior to any screening procedure
- Subject in good health (COHb 10mg/dL)
- Healthy adult capable of undergoing controlled hypoxemia to the level called for in the protocol with minimal medical risk
Exclusion Criteria
- Smokers or individuals exposed to high levels of carbon monoxide that result in elevation of carboxy hemoglobin levels
- Individual subject to conditions that result in elevated levels of methemoglobin
- Subject who would be placed at undue medical risk associated with any procedure called for in the protocol
- Subject with open wounds
- Pregnant woman (negative pregnancy test needed)
- Subject allergic to silicon, polyamide and silver yarn
- Subject with cardiorespiratory disorders likely to worsen with thoracic pressure applied by the textile band
- Subject with mental or motor impairment preventing him from expressing pain
- Subject with blood or skin disorder that may impacting results
- Subject with behavioral disorders, too agitated or too aggressive
- Subject with sensorial disorders, insensible to skin pain
- Subject susceptible to tension/pressure based headaches
Data sourced from ClinicalTrials.gov (NCT03614416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.