About this trial
Specificity measure of performance of the Irregular Heartbeat Detection algorithm (evaluated for the finger and wrist form factors) against the Masimo Radius VSM® reference ECG. Each form factor will be evaluated independently of one another
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject is 18 to 80 years of age.
Comfortable to read and communicate in English.*
Subject passes the health assessment conducted by qualified study personnel, confirming they are in adequate health to participate in the required procedures
This is to ensure the participant can provide informed consent and can comply with study procedures (as study material are currently available in English only).
Disqualifiers
Subject currently has a known cardiac disease condition.
Subject is pregnant or breastfeeding.
Subjects with a skin condition affecting the digits/chest, where the sensors are applied which would interfere with the path of lights (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown) or sensor adhesion.
Skin condition which would preclude proper ECG placement.
Trial design
Single group
Treatments tested in this trial
Masimo SET® and Masimo W1®
DevicePulse oximeter and wrist wearable device
Treatment groups
Trial outcomes
Primary outcomes
Specificity of Masimo SET®
Specificity of Masimo W1®
Sponsors and contacts
Click on the lead sponsor to view all of their trials.