HypoxiaNCT03439306
Accuracy Validation of Belun Oxygen Saturation Pulse Oximeter FDA Submission Study
An observational study of Hypoxia, run by Belun Technology Company Limited at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the oxygen saturation accuracy performance of Belun Ring Oximeter placed on the index fingers during non-motion conditions 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?
- Pulse Oximeter
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2017to 17 Mar 2017
- Phase
- Observational
- 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
Study population: healthy adult volunteer. The skin pigmentation / tones ranged from light to dark meeting the requirement of at least 2 darkly pigmented or 15 % of the subject pool whichever is larger.
Who may be able to join
- 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.
- Male or female of any race.
- Subject demographics include a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.
Who cannot join
- Subject is considered as being morbidly obese (defined as BMI large than 39.5).
- Compromised circulation, injury, or physical malformation of fingers, toes, 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.)
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study.
- Subjects with COHb levels larger than 3% as assessed with a Masimo Radical 7 (Rainbow).
- Subjects with known respiratory conditions such as (self-reported) uncontrolled / severe asthma, flu, pneumonia / bronchitis, shortness of breath / respiratory distress, respiratory or lung surgery, emphysema, COPD, lung disease.
- Subjects with known heart or cardiovascular conditions such as: (self-reported), except for blood pressure and ECG review) hypertension, have had cardiovascular surgery, Chest pain (angina), heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia, 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.
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- Self-reported health conditions as identified in the Health Assessment Form (self-reported), diabetes, 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 head injury, 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).
- Unwillingness or inability to remove colored nail polish from test digits.
- Other known health condition, should be considered upon disclosure in health assessment form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy Validation of Belun SpO2 Pulse Oximeter FDA Submission Study
The purpose of this study is to evaluate the oxygen saturation accuracy performance of Belun Ring Oximeter placed on the index fingers during non-motion conditions
Read the detailed description
The purpose of this study is to evaluate the SpO2 accuracy performance of Belun Ring Oximeter placed on the index fingers during non-motion conditions over the range of 70-100% SaO2, arterial blood samples, assessed by CO-Oximetry. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70 - 100% SaO2.
The Clinimark proprietary Desaturation Fixture with Automated Data Collection is a single limb blow by system used to deliver medical grade oxygen and nitrogen gas mixtures to induce various hypoxic levels in subjects at a slow steady rate allowing an automatic marking and collection of the Control or secondary Transfer reference Pulse Oximeter and other pulse oximetry systems at 1 second intervals.
The Control Pulse Oximeter, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability of the data.
Multi-parameter monitor used during the study to observe a subject's vital signs including ECG tracing, heart rate, respiratory rate, end-tidal CO2 with capnograph, secondary monitor for the oxygen concentration being delivered to the subject.
A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.
- Conditions
- Hypoxia
- Being tested
- Pulse Oximeter
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse OximeterDevice
The Pulse Oximeter are placed on the left and right Index fingers of each subject of the healthy adult volunteer group to evaluate the SpO2 accuracy performance.
| Study group | Role | What they receive |
|---|---|---|
| healthy adult volunteer | Subject is 18 to 50 years of age.
Subject is a non-smoker or who has not smoked within 2 days prior to the study. Receives: Device: Pulse Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect SpO2 data for accuracy statistical analysis by 11 subjects
Subjects were given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70%. The stable plateaus allowed data collection in the following SaO2 ranges 95-100, 90-95, 85-90, 80-85, 75-80, 67-75. In general, 4 to 8 discrete points were collected at each of the levels.
Measured: 3 days
Accuracy data analysis
Data analysis follows ISO80601-2-61:2011, Annex EE and Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start15 Mar 2017
- Primary completion17 Mar 2017
- Study completion17 Mar 2017
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belun Technology Company Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
- Investigators
- Arthur Ruiz Cabrera, M.D., Principal investigator, Clinimark, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439306
- Sponsor's protocol ID
- PR-2016-207
- Status last verified
- Feb 2018
- First submitted
- 14 Feb 2018
- Last updated
- 20 Feb 2018
- 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 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Validation of Belun SpO2 Pulse Oximeter FDA Submission Study
- ClinicalTrials.gov ID
- NCT03439306
- Acronym / sponsor ID
- PR-2016-207
- Conditions
- Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Belun Technology Company LimitedUniversity, hospital or other
- Collaborators
- Clinimark, LLC
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 20 Feb 2018 (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 study is to evaluate the oxygen saturation accuracy performance of Belun Ring Oximeter placed on the index fingers during non-motion conditions
Detailed description
The purpose of this study is to evaluate the SpO2 accuracy performance of Belun Ring Oximeter placed on the index fingers during non-motion conditions over the range of 70-100% SaO2, arterial blood samples, assessed by CO-Oximetry. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70 - 100% SaO2.
The Clinimark proprietary Desaturation Fixture with Automated Data Collection is a single limb blow by system used to deliver medical grade oxygen and nitrogen gas mixtures to induce various hypoxic levels in subjects at a slow steady rate allowing an automatic marking and collection of the Control or secondary Transfer reference Pulse Oximeter and other pulse oximetry systems at 1 second intervals.
The Control Pulse Oximeter, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability of the data.
Multi-parameter monitor used during the study to observe a subject's vital signs including ECG tracing, heart rate, respiratory rate, end-tidal CO2 with capnograph, secondary monitor for the oxygen concentration being delivered to the subject.
A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy adult volunteer | – | Device: Pulse OximeterSubject is 18 to 50 years of age. Subject is a non-smoker or who has not smoked within 2 days prior to the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy adult volunteer. The skin pigmentation / tones ranged from light to dark meeting the requirement of at least 2 darkly pigmented or 15 % of the subject pool whichever is larger.
Key inclusion criteria (6 listed)
- 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.
- Male or female of any race.
Key exclusion criteria (11 listed)
- Subject is considered as being morbidly obese (defined as BMI large than 39.5).
- Compromised circulation, injury, or physical malformation of fingers, toes, 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.)
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study.
- Subjects with COHb levels larger than 3% as assessed with a Masimo Radical 7 (Rainbow).
- Subjects with known respiratory conditions such as (self-reported) uncontrolled / severe asthma, flu, pneumonia / bronchitis, shortness of breath / respiratory distress, respiratory or lung surgery, emphysema, COPD, lung disease.
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 |
|---|---|---|
| Pulse OximeterThe Pulse Oximeter are placed on the left and right Index fingers of each subject of the healthy adult volunteer group to evaluate the SpO2 accuracy performance. | Device | healthy adult volunteer |
Primary outcome
Collect SpO2 data for accuracy statistical analysis by 11 subjects
Time frame: 3 days
Subjects were given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70%. The stable plateaus allowed data collection in the following SaO2 ranges 95-100, 90-95, 85-90, 80-85, 75-80, 67-75. In general, 4 to 8 discrete points were collected at each of the levels.
Accuracy data analysis
Time frame: 3 days
Data analysis follows ISO80601-2-61:2011, Annex EE and Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)
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 20 Feb 2018.
- 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.
Arthur Ruiz Cabrera, M.D. principal investigator
Clinimark, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia, run by Belun Technology Company Limited 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 11 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 20 Feb 2018. 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?
Collect SpO2 data for accuracy statistical analysis by 11 subjects (time frame: 3 days). 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 20 Feb 2018; AzTrials last refreshed its copy on 7 Nov 2026.