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HypoxiaNCT03918018

BiOSENCY BORA Band SpO2 Validation Study

A study testing BORA Band SpO2 Validation Study in people with Hypoxia, run by Biosency at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Hypoxia
What is being tested?
BORA Band SpO2 Validation Study
Type of treatment
Medical device
How many people
10 participants
Where
1 siteUnited States
Study dates
19 Feb 2019to 21 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of either
  • Subject must have the ability to understand and provide written informed consent
  • Subject is 18 to 50 years of age
  • Subject must be willing and able to comply with study procedures and duration
  • Subject is a non-smoker or who has not smoked within 2 days prior to the study
  • Wrist size should be between 15-23 cm (5.9 - 9 inches)

Who cannot join

  • Subject is considered as being morbidly obese (defined as BMI >39.5)
  • Compromised circulation, injury, or physical malformation of fingers, wrist, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
  • Female subjects that are actively trying to get pregnant or are pregnant (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential).
  • Smoker Subjects who have refrained will be screened for COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
  • Subjects with known respiratory conditions such as: (self-reported)
  • uncontrolled / severe asthma,
Show all 48Show fewer
  • flu,
  • pneumonia / bronchitis,
  • shortness of breath / respiratory distress,
  • unresolved respiratory or lung surgery with continued indications of health issues ,
  • emphysema, COPD, lung disease
  • Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
  • hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings (reviewed during health screen).
  • have had cardiovascular surgery
  • Chest pain (angina)
  • heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
  • previous heart attack
  • blocked artery
  • unexplained shortness of breath
  • congestive heart failure (CHF)
  • history of stroke
  • transient ischemic attack
  • carotid artery disease
  • myocardial ischemia
  • myocardial infarction
  • cardiomyopathy
  • Self-reported health conditions as identified in the Health Assessment Form (self-reported)
  • diabetes,
  • uncontrolled thyroid disease,
  • kidney disease / chronic renal impairment,
  • history of seizures (except childhood febrile seizures),
  • epilepsy,
  • history of unexplained syncope,
  • recent history of frequent migraine headaches,
  • recent symptomatic head injury (within the last 2 months)
  • cancer / chemotherapy
  • Subjects with known clotting disorders (self-reported)
  • history of bleeding disorders or personal history of prolonged bleeding from injury
  • history of blood clots
  • hemophilia
  • current use of blood thinner: prescription or daily use of aspirin
  • Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
  • Subjects with severe allergies to iodine (only applicable if iodine is used)
  • Subjects with severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocaine)
  • Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio < 0.4)
  • Unwillingness or inability to remove colored nail polish from test digits.
  • Other known health condition, should be considered upon disclosure in health assessment form
  • Wrist size should be between 15-23 cm (5.9 - 9 inches)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinimark Desaturation Laboratory

    Louisville, Colorado, 80027

Other trials in United States

About this study

Official title: SpO2 and Pulse Rate Accuracy Comparison of BiOSENCY BORA Band to Arterial Blood CO-Oximetry and Reference ECG

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.

Read the detailed description

The SpO2 accuracy performance of BiOSENCY BORA BAND™ wristband Pulse Oximeter will be evaluated during non-motion conditions over the range of 70-100% SaO2 and compared to arterial blood samples assessed by CO-Oximetry. A minimum of 10 healthy adult male and female subjects, ranging in age and pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61:2017 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). The subjects will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. The investigational device will be placed on the wrist opposite for the test per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.

For the data analysis, the control oximeter will be used to assess the stability of each data point. Data that is found to be unstable will be removed prior to the comparative analysis. The CO-Oximeter data will be reviewed to make sure it does not contain any anomalous values such as elevated, low or inconsistent COHb, MetHb, or tHb data. Anomalous values will be removed from the analysis prior to pairing of the SpO2 and SaO2 data. The statistical analysis is performed on a minimum of 200 data points collected from at least 10 subjects for the range of 70% to 100% SaO2 with allowance of ± 3% of the target range. Functional SaO2 as measured by Reference CO-Oximetry will be used as the basis for comparison. The Accuracy Root Mean Square (ARMS) calculation is used to determine the SpO2 accuracy performance. Success will be achieved with an ARMS of 3.5 or better showing equivalence to the Gold Standard Reference CO-Oximetry providing documentation to support SpO2 accuracy claims for the investigational device.

The study population will include 10-15 healthy non-smoking (or has refrained from smoking for 2 days) competent adults, 18-50 years of age. The subject selection will be an equitable distribution of males and females of any race with varying skin tones including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger. The subjects must understand the study and consent to participate by signing the Informed Consent Form. The subjects must be healthy showing no evidence of medical problems as indicated by satisfactorily completing the health assessment form.

Conditions
Hypoxia
Being tested
BORA Band SpO2 Validation Study
Keywords
Pulse oximetry
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BORA Band SpO2 Validation StudyDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of BORA Band SpO2 measurements versus arterial blood co-oximetry

    Accuracy of the BORA Band SpO2 measurement as compared to reference co-oximetry performed on arterial blood samples.

    Results shall include

    • SpO2 Root mean square accuracy of BORA Band
    • SpO2 Bias of BORA Band
    • Bland-Altman plots with linear regression line and 95% upper and lower limits of agreement

    Measured: 1 day

  2. Accuracy of BORA Band Pulse Rate measurements versus electrocardiogram readings

    Accuracy of the BORA Band pulse rate measurement as compared to reference electrocardiogram readings.

    Results shall include

    • Pulse rate Root mean square accuracy of BORA Band
    • Pulse rate Bias of BORA Band

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2019
  2. Study start19 Feb 2019
  3. Primary completion21 Feb 2019
  4. Study completion21 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03918018
Sponsor's protocol ID
PR2018-312
Status last verified
Apr 2019
First submitted
4 Apr 2019
Last updated
17 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BORA Band SpO2 Validation Study in people with Hypoxia, run by Biosency at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of BORA Band SpO2 measurements versus arterial blood co-oximetry (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03918018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.

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