Trial Outcomes & Findings for Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer (NCT NCT03614416)

Last Updated: 2021-01-12

Results Overview

For each desaturation plateau, SpO2 ARMS are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

1 day

Results posted on

2021-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	EOXY Device and Gold Standard Oximeter and SaO2 Measures Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EOXY Device and Gold Standard Oximeter and SaO2 Measures n=10 Participants Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	23.5 years n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment Belgium	10 participants n=99 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Subjects respecting the study conditions (no movements, good irrigation) 3 subjects excluded from analysis(no respect of study conditions) so 10 subjects analyzed

For each desaturation plateau, SpO2 ARMS are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements

Outcome measures

Outcome measures
Measure	EOXY Device and Gold Standard Oximeter and SaO2 Measures n=10 Participants Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position Overall range 70-100% of O2	3.91 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position 97-100% of O2	3.08 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position 97-92% of O2	3.36 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position 92-85% of O2	2.85 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position 84-78% of O2	3.48 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position 77-70% of O2	6.21 percentage of ARMS (accuracy)

PRIMARY outcome

Timeframe: 1 day

Population: Subjects respecting the study conditions (no movements, good irrigation) 3 subjects excluded from analysis(no respect of study conditions) so 10 subjects analyzed

For each desaturation plateau, SpO2 ARMS (Accuracy Root-Mean Square) are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements

Outcome measures

Outcome measures
Measure	EOXY Device and Gold Standard Oximeter and SaO2 Measures n=10 Participants Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position Overall range 70-100% of O2	11.14 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position 97-100% of O2	12.99 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position 97-92% of O2	12.51 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position 92-85% of O2	9.91 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position 84-78% of O2	7.31 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position 77-70% of O2	10.76 percentage of ARMS (accuracy)

PRIMARY outcome

Timeframe: 1 day

For each desaturation plateau, SpO2 ARMS are calculated by the difference between the investigational pulse oximeter SpO2 measurement and the co-oximeter's SaO2 measurements

Outcome measures

Outcome measures
Measure	EOXY Device and Gold Standard Oximeter and SaO2 Measures n=10 Participants Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position Overall range 70-100% of O2	6.02 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position 97-100% of O2	7.09 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position 97-92% of O2	6.63 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position 92-85% of O2	6.57 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position 84-78% of O2	5.06 percentage of ARMS (accuracy)
Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position 77-70% of O2	3.96 percentage of ARMS (accuracy)

PRIMARY outcome

Timeframe: 1 day

Population: People respecting study conditions (good irrigation and no movements)

For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements

Outcome measures

Outcome measures
Measure	EOXY Device and Gold Standard Oximeter and SaO2 Measures n=10 Participants Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
HR Accuracy Root-Mean Square (ARMS) at Forehead Position 92-85% of O2	11.5 percentage of ARMS (accuracy)
HR Accuracy Root-Mean Square (ARMS) at Forehead Position Overall range 70-100% of O2	12.2 percentage of ARMS (accuracy)
HR Accuracy Root-Mean Square (ARMS) at Forehead Position 97-100% of O2	10.0 percentage of ARMS (accuracy)
HR Accuracy Root-Mean Square (ARMS) at Forehead Position 97-92% of O2	11.7 percentage of ARMS (accuracy)
HR Accuracy Root-Mean Square (ARMS) at Forehead Position 84-78% of O2	14.3 percentage of ARMS (accuracy)
HR Accuracy Root-Mean Square (ARMS) at Forehead Position 77-70% of O2	13.0 percentage of ARMS (accuracy)

PRIMARY outcome

Timeframe: 1 day

Population: People respecting study conditions (good irrigation, no movements)

For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements

Outcome measures

Outcome measures
Measure	EOXY Device and Gold Standard Oximeter and SaO2 Measures n=10 Participants Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position Overall range 70-100% of O2	32.1 percentage of ARMS (accuracy)
Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position 97-100% of O2	30.8 percentage of ARMS (accuracy)
Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position 97-92% of O2	31.5 percentage of ARMS (accuracy)
Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position 92-85% of O2	31.5 percentage of ARMS (accuracy)
Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position 84-78% of O2	30.4 percentage of ARMS (accuracy)
Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position 77-70% of O2	36.5 percentage of ARMS (accuracy)

PRIMARY outcome

Timeframe: 1 day

Population: People respecting study conditions (good irrigation and no movements)

For each desaturation plateau, HR ARMS are calculated by the difference between the investigational pulse oximeter HR measurement and the HR gold standard measurements

Outcome measures

Outcome measures
Measure	EOXY Device and Gold Standard Oximeter and SaO2 Measures n=10 Participants Heart rate and SPO2 measures provided from EOXY device Heart rate measures provided from gold standard oximeter. SaO2 measures provided from blood sampling There is only one arm: all subjects have simultaneously three interventions (as required in the European standard ISO 80601-2-61), to qualify a pulse oximeter EOXY device: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard Gold standard oximeter: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard SaO2 sampling: Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position Overall range 70-100% of O2	21.1 percentage of ARMS (accuracy)
Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position 97-100% of O2	22.3 percentage of ARMS (accuracy)
Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position 97-92% of O2	24.6 percentage of ARMS (accuracy)
Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position 92-85% of O2	19.2 percentage of ARMS (accuracy)
Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position 84-78% of O2	19.1 percentage of ARMS (accuracy)
Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position 77-70% of O2	20.6 percentage of ARMS (accuracy)

Adverse Events

EOXY Device and Gold Standard Oximeter and SaO2 Measures

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eléonore CAILLET

Bioserenity

Phone: 01 57 27 40 00.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place