Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Arterial line, Motion · 1 trial · 2 indications
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.
For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.
| Arm | Type | Description |
|---|---|---|
| Arterial Line | EXPERIMENTAL | CO-Oximetry value obtained as a comparator. Obtained during motion conditions. |
| Motion | EXPERIMENTAL | The subject has to perform motions during the procedure. This is to verify that device is able to read through motion. |
| Name | Type | Description |
|---|---|---|
| Arterial line | DEVICE | Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601 |
| Motion | DEVICE | The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure. |
Inclusion Criteria: * Male or female of any race * 18-50 years old, inclusive * Females: negative urine pregnancy test on the day of study participation (prior to exposure to hypoxia) * Completed within the last year: physical exam by a licensed physician, physician assistant (PA), or advanced prac...
Arterial line, Motion is a device being studied for use in healthy individuals under controlled hypoxia, or low oxygen conditions. It is being evaluated in a clinical trial that compares pulse oximetry readings to arterial blood samples during motion. The study is in Phase 3 and is being developed by Medtronic plc.
Medtronic plc, traded under the ticker MDT, is the developer of Arterial line, Motion. The company is conducting a Phase 3 clinical trial for this device, which is being studied in healthy volunteers under hypoxic conditions. The trial is completed and took place in the United States.
Arterial line, Motion is in Phase 3 clinical development. It is an investigational device and has not been approved. The Phase 3 trial, which is completed, enrolled 18 healthy participants and was conducted in the United States. The study was controlled but not randomized or double-blinded.
Arterial line, Motion has one completed Phase 3 clinical trial, identified as NCT02247765. The trial, titled 'Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion,' enrolled 18 healthy adults in the United States. The study was controlled and included conditions of healthy and hypoxia.
Arterial line, Motion is not FDA approved. It is an investigational device currently in Phase 3 clinical development. The completed trial, NCT02247765, studied the device in healthy volunteers under hypoxic conditions, but approval status has not been established. Medtronic plc is the developer.