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BiOSENCY BORA Band SpO2 Validation Study

NCT03918018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-04-17

No results posted yet for this study

Summary

The purpose of this clinical study is to validate the SpO2 accuracy of the BiOSENCY BORA BAND™ wristband Pulse Oximeter during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of BORA BAND™ wristband Pulse Oximeter.

It is required that the Accuracy Root Mean Square (ARMS) performance of the BORA BAND™ wristband Pulse Oximeter will meet a specification of 3.5 or better in non-motion conditions for the range of 70 - 100% SpO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.

Conditions

Interventions

DEVICE

BORA Band SpO2 Validation Study

Qualified healthy volunteers will be enrolled into the study. Subjects will recline for the study. Reference sensor(s) will be placed on each subject to evaluate the SpO2 accuracy and performance. Shield material may be used between any adjacent finger sensors to prevent optical crosstalk. Simultaneous data collection will be set up for device under test and the control pulse oximeter. The data from the test device will be collected by the sponsor or trained Clinimark Study staff. Data will be collected for 1 second intervals data analysis. The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%. The investigational device will only be placed on the wrist. The control pulse oximeter may be alternated through fingers between subjects.

Sponsors & Collaborators

  • Clinimark, LLC

    collaborator OTHER

  • Biosency

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2019-02-21
Completion
2019-02-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03918018 on ClinicalTrials.gov