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

NCT03614416 | Completed Results

• 1 other identifier: BIOSERENITY_80601-2-61
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Forehead Position

  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

  1 day

• Percentage SPO2 Accuracy Root-Mean Square (ARMS) at Torso Position

  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

  1 day

• Percentage SPO2 Accuracy Root-Mean Square (ARMS) at BACK Position

  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

  1 day

• HR Accuracy Root-Mean Square (ARMS) at Forehead Position

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

  1 day

• Percentage of HR Accuracy Root-Mean Square (ARMS) at TORSO Position

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

  1 day

• Percentage of HR Accuracy Root-Mean Square (ARMS) at BACK Position

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

  1 day

Study Arms (1)

EOXY device and Gold standard oximter and SaO2 measures

EXPERIMENTAL

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

Device: EOXY device; Device: Gold standard oximeter; Procedure: SaO2 sampling

Interventions

EOXY device DEVICE

Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard

EOXY device and Gold standard oximter and SaO2 measures

Gold standard oximeter DEVICE

Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard

EOXY device and Gold standard oximter and SaO2 measures

SaO2 sampling PROCEDURE

Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard

EOXY device and Gold standard oximter and SaO2 measures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subject (Man/ Women) \> 18 years old
• Subject signed informed consent prior to any screening procedure
• Subject in good health (COHb \< 3% , MetHb \< 2%, CtHb \> 10mg/dL)
• Healthy adult capable of undergoing controlled hypoxemia to the level called for in the protocol with minimal medical risk

You may not qualify if:

• 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

Sponsors & Collaborators

• BioSerenity: lead
• NAMSA: collaborator
• Université Catholique de Louvain: collaborator

Study Sites (1)

Université catholique louvain la neuve, centre sportif

Louvain-la-Neuve, 1348, Belgium

Location

Results Point of Contact

• Title: Eléonore CAILLET
• Organization: Bioserenity

eleonore.caillet@bioserenity.com

01 57 27 40 00.

Study Officials

• marc FRANCAUX

  UNIVERSITE CATHOLIQUE DE LOUVAIN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: No randomisation. All subjects will test simultaneously the gold standard and the EOXY device

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: August 3, 2018
• Study Start: December 8, 2017
• Primary Completion: December 15, 2017
• Study Completion: November 6, 2018
• Last Updated: January 12, 2021
• Results First Posted: January 12, 2021

Record last verified: 2020-12

Locations

BE (1)