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.
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
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.
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
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.
- First posted17 Apr 2019
- Study start19 Feb 2019
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Biosency
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 and Pulse Rate Accuracy Comparison of BiOSENCY BORA Band to Arterial Blood CO-Oximetry and Reference ECG
- ClinicalTrials.gov ID
- NCT03918018
- Acronym / sponsor ID
- PR2018-312
- Conditions
- Hypoxia
- Keywords
- Pulse oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- BiosencyIndustry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (48 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BORA Band SpO2 Validation StudyQualified 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. | Device | – |
Primary outcome
Accuracy of BORA Band SpO2 measurements versus arterial blood co-oximetry
Time frame: 1 day
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
Accuracy of BORA Band Pulse Rate measurements versus electrocardiogram readings
Time frame: 1 day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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?
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.