Accuracy Validation of Belun Oxygen Saturation Pulse Oximeter FDA Submission Study

Completed

Conditions studied: Hypoxia

In brief

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

Key facts

Study ID

NCT03439306

Run by

Belun Technology Company Limited

People needed

11

Starts

2017-03-15

Expected to finish

2017-03-17

Last updated by the study team

2018-02-20

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Clinimark, LLC — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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