Heart Rate Clinical Trial
Official title:
Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor
This is a prospective pivotal study in patients admitted/visiting the cardiology ward and/or
outpatient clinics for various indications.
The study will be conducted in two stages. The first stage will comprise a pilot study with
10 subjects, which will be completed and analyzed prior to initiation of the second stage.
The two studies are independent and are included in the same protocol for logistical reasons.
The second stage of the study, which will include 120 subjects, is pivotal and intended to
validate the Gili BioSensor System.
Testing procedure will include seating the subject in either a steady chair in front of a
table, or in bed with the bedrest raised in front of a cardiac table (or similar). The
subject will be seated for 5 minutes to reach a physiological steady state. During this time,
the subject will be connected to the reference device according to the manufacturer's
guidelines. The investigational device will be placed on a stable surface in front of the
subject (table / cardiac table or similar) and will point to the left side of the subject's
chest. Both the investigational and reference devices will be temporally synchronized to
maintain coordinated recording. Following the 5-minute resting period, both investigational
and reference devices will be activated for a comparative recording session to acquire at
least 180 seconds (3 minutes) of evaluable data. Each 60-sec interval will be used separately
for comparative analyses.
n/a
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